VOLK OPTICAL INC.

VOLK OPTICAL INC.

Address:7893 ENTERPRISE DR.,Mentor,OH,44060,US

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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

Lens, Condensing, Diagnostic (HJL) (10)

Premarket Exempt

No Yes

Clear

14D Large Clear - 00811608010007 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

15D Large Clear - 00811608010014 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear - 00811608010021 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear ACS® PermaView - 00811608010038 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear, Red Ring - 00811608010045 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear, Blue Ring - 00811608010052 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear, Purple Ring - 00811608010069 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear, Green Ring - 00811608010076 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear, Gold Ring - 00811608010083 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

20D Large Clear, Silver Ring - 00811608010090 Catalog Number :

Device Class : 1

Duns Number: 071125835

Premarket Exempt : Yes

Product Code : HJL

Prescription Use : No

Device Count : 1

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