The following data is part of a premarket notification filed by Cliff Weil, Inc. with the FDA for Regency, Compare, Sun Optics Sunglasses.
| Device ID | K913419 |
| 510k Number | K913419 |
| Device Name: | REGENCY, COMPARE, SUN OPTICS SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | CLIFF WEIL, INC. P.O. BOX 427 Mechanicsville, VA 23111 |
| Contact | Jerry Schwartzlow |
| Correspondent | Jerry Schwartzlow CLIFF WEIL, INC. P.O. BOX 427 Mechanicsville, VA 23111 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-31 |
| Decision Date | 1992-02-12 |