The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Keymed Key Light.
| Device ID | K813133 |
| 510k Number | K813133 |
| Device Name: | KEYMED KEY LIGHT |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KEYMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-05 |
| Decision Date | 1981-11-20 |