The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Opmi L Stereo-laparoscope.
| Device ID | K931478 |
| 510k Number | K931478 |
| Device Name: | ZEISS OPMI L STEREO-LAPAROSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-24 |
| Decision Date | 1994-09-28 |