The following data is part of a premarket notification filed by Clearvision Optical Co., Inc. with the FDA for Frame-spectacle.
| Device ID | K933765 |
| 510k Number | K933765 |
| Device Name: | FRAME-SPECTACLE |
| Classification | Frame, Spectacle |
| Applicant | CLEARVISION OPTICAL CO., INC. 50 HEMPSTEAD GARDENS DR. West Hempstead, NY 11552 |
| Contact | Fred Friedfeld |
| Correspondent | Fred Friedfeld CLEARVISION OPTICAL CO., INC. 50 HEMPSTEAD GARDENS DR. West Hempstead, NY 11552 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1993-10-18 |