The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Cpc Probe.
| Device ID | K961380 |
| 510k Number | K961380 |
| Device Name: | CPC PROBE |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-10 |
| Decision Date | 1997-03-17 |
| Summary: | summary |