VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
FDA 510(k) clearance K952597 · decided 1995-09-12
Clearance details
- K-number
- K952597
- Device name
- VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
- Applicant
- Point of View Optical Outlet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-06
- Decision date
- 1995-09-12
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- HQZ
- Device class
- 1
- Regulation number
- 886.5842
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Aventura, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPECTACLE FRAME (K944313) | Sun Hing Optical Manufactory , Ltd. | 1995-03-28 |
| SPECTACLE FRAME (K945392) | Seo Han Corp., Ltd. | 1994-12-15 |
| SPECTACLE FRAME OR EYEGLASS FRAMES (K945176) | Optipia Trading Co. | 1994-12-15 |
| OPTICAL FRAMES (K945770) | Ramada Optics, Inc. | 1994-12-15 |
| FRAME, SPECTACLES (K945350) | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| MAG-1 SPECTACLE FRAME (K945342) | Criss Optical Mfg. Co., Inc. | 1994-11-28 |
| ARISTAR EYEWEAR, ESPRIT EYEWEAR (K945123) | Aristar Inc. U.S.A. | 1994-11-22 |
| SPECTACLE FRAMES OR EYEGLASS FRAMES (K945340) | Mi Mun Corp. | 1994-11-22 |
| SPECTACLE FRAME (K945323) | M.Y. Vision Corp. | 1994-11-22 |
| FRAME, SPECTACLE (K945450) | Kookje Apis Industrial Co. | 1994-11-22 |
| NIL (K944641) | Max-Vision (H.K.)Limited | 1994-11-14 |
| SPECTACLE FRAMES (K944373) | Custom Optical Frames, Inc. | 1994-09-28 |
Recalls involving this device
No recalls on record reference this clearance.