The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Endolive Stero Endoscope.
| Device ID | K950985 |
| 510k Number | K950985 |
| Device Name: | ZEISS ENDOLIVE STERO ENDOSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-03-29 |