The following data is part of a premarket notification filed by Point Of View Optical Outlet, Inc. with the FDA for View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun Pockets, Point Of View.
| Device ID | K952597 |
| 510k Number | K952597 |
| Device Name: | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW |
| Classification | Frame, Spectacle |
| Applicant | POINT OF VIEW OPTICAL OUTLET, INC. 18757 BISCAYNE BLVD. Aventura, FL 33180 |
| Contact | Jacky Amar |
| Correspondent | Jacky Amar POINT OF VIEW OPTICAL OUTLET, INC. 18757 BISCAYNE BLVD. Aventura, FL 33180 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-06 |
| Decision Date | 1995-09-12 |