I-TEK MEDICAL SOLUTIONS, INC.

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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

Retractor, Fiberoptic (FDG) (3) Light Source, Fiberoptic, Routine (FCW) (1)

Premarket Exempt

Yes

Clear

I-Tek I-150 LED Light Source - 00869836000307 Catalog Number : I-150

Device Description : The LED Light Source is the light source for use with the Medical Illumination L The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size with a small footprint, light, easily portable, has infinitely variable light output and is maintenance free with a long lifetime expectancy.

Device Class : 2

Duns Number: 080599644

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : No

Device Count : 1

Fiber Optic Illuminator - 00869836000314 Catalog Number :

Device Class : 1

Duns Number: 080599644

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : Yes

Device Count : 1

Fiber Optic Illuminator - 00869836000321 Catalog Number :

Device Class : 1

Duns Number: 080599644

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : Yes

Device Count : 1

Fiber Optic Illuminator - 00869836000345 Catalog Number :

Device Class :

Duns Number: 080599644

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : Yes

Device Count : 1

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