BURTON MEDICAL PRODUCTS CORPORATION

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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, Ceiling Mounted (FSY) (10)

Premarket Exempt

Clear

AIM 200 - 00858480006100 Catalog Number : 6000159-2

Device Description : WALL MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

APEX - 00858480006117 Catalog Number : 6000194

Device Description : LIGHT HEAD

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

APEX - 00858480006124 Catalog Number : 6000205-5

Device Description : SINGLE CEILING MOUNT (8FT.)

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

APEX - 00858480006148 Catalog Number : 6000205-2

Device Description : SINGLE CEILING MOUNT (10FT.)

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

APEX - 00858480006155 Catalog Number : 6000214-5

Device Description : DOUBLE CEILING MOUNT (8FT.)

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

APEX - 00858480006162 Catalog Number : 6000214-2

Device Description : DOUBLE CEILING MOUNT (10FT.)

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 200 - 00858480006209 Catalog Number : 4000104

Device Description : SPRING ARM

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006223 Catalog Number : 1017000-3

Device Description : LIGHT HEAD

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006230 Catalog Number : 1017444-7

Device Description : DOUBLE CEILING MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006247 Catalog Number : 6000184-7

Device Description : FLOOR BASE ASSEMBLY

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

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