LONG ISLAND TECH

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Filters

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

Light, Surgical, Endoscopic (FSW) (10)

Premarket Exempt

Yes

Clear

AtoN Keywest Headlight without Fiber Optic Cable - 00851610007091 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

Hatteras - 00851610007107 Catalog Number :

Device Description : Light, Surgical, Endoscopic

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Optic Only - 00851610007114 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Classic Headlight without Fiber Optic Cable - 00851610007121 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Classic Headlight with Cobra Fiber Optic Cable - 00851610007138 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Classic Headlight with 10' Fiber Optic Cable - 00851610007145 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Keywest Headlight with Cobra Fiber Optic Cable - 00851610007152 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Keywest Headlight with 10' Fiber Optic Cable - 00851610007169 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Keywest Headlight with 7' Fiber Optic Cable - 00851610007176 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

AtoN Classic Headlight with 7' Fiber Optic Cable - 00851610007183 Catalog Number :

Device Description : Light, Surgical, Endoscopic, Accessory

Device Class : 2

Duns Number: 030256600

Premarket Exempt : Yes

Product Code : FSW

Prescription Use : Yes

Device Count : 1

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