The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber Optic Endoscope.
| Device ID | K922826 |
| 510k Number | K922826 |
| Device Name: | FLEXIBLE FIBER OPTIC ENDOSCOPE |
| Classification | Kit, Nephroscope |
| Applicant | OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange, CA 92665 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange, CA 92665 |
| Product Code | FGA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-11 |
| Decision Date | 1993-02-19 |