The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber Optic Laparoscopes.
| Device ID | K943598 |
| 510k Number | K943598 |
| Device Name: | FLEXIBLE FIBER OPTIC LAPAROSCOPES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OPTIMED TECHNOLOGIES, INC. 1411 N. BATAVIA ST. SUITE 114 Orange, CA 92667 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen OPTIMED TECHNOLOGIES, INC. 1411 N. BATAVIA ST. SUITE 114 Orange, CA 92667 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1994-10-18 |