The following data is part of a premarket notification filed by Kenmark Optical Co., Inc. with the FDA for Spectacle Frame.
| Device ID | K935918 |
| 510k Number | K935918 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | KENMARK OPTICAL CO., INC. 1825 CARGO CT. Louisville, KY 40299 |
| Contact | Mike Cundiff |
| Correspondent | Mike Cundiff KENMARK OPTICAL CO., INC. 1825 CARGO CT. Louisville, KY 40299 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-09 |
| Decision Date | 1994-02-16 |