The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Gm Opti*cam Camera With Fiber Optic Light.
| Device ID | K941660 |
| 510k Number | K941660 |
| Device Name: | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT |
| Classification | Endoscope, Ophthalmic |
| Applicant | GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Contact | David C Steffin |
| Correspondent | David C Steffin GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
| Product Code | KYH |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-05 |
| Decision Date | 1994-05-24 |