MICROSPECIALITIES, INC.

Address:430 Smith St,Middletown,CT,06457,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Keratome, Ac-Powered (HNO) (10)

Premarket Exempt

No Yes

Clear

NA - 10810003220346 Catalog Number : MK-800800-20

Device Description : MicroKeratome Blades, Laser Calibrated NIDEK minus 20 Have the ultimate control MicroKeratome Blades, Laser Calibrated NIDEK minus 20 Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns.

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221046 Catalog Number : MK-100100

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, Plano. Have the ult MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, Plano. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221053 Catalog Number : MK-100100-10

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 10. Have the MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221060 Catalog Number : MK-100100-20

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 20. Have the MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 20. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221077 Catalog Number : MK-100100-30

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 30. Have the MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 30. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221084 Catalog Number : MK-100100-40

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 40. Have the MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 40. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221091 Catalog Number : MK-100100+10

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, plus 10. Have the u MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, plus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221107 Catalog Number : MK-100100+20

Device Description : MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, PLUS 20. Have the u MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, PLUS 20. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221114 Catalog Number : MK-101101

Device Description : MicroKeratome Blades, Laser Calibrated XP, Plano. Have the ultimate control of MicroKeratome Blades, Laser Calibrated XP, Plano. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221121 Catalog Number : MK-101101-10

Device Description : MicroKeratome Blades, Laser Calibrated XP minus 10. Have the ultimate control of MicroKeratome Blades, Laser Calibrated XP minus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

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