The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Opmi Twiner Surgical Microscope.
| Device ID | K983868 |
| 510k Number | K983868 |
| Device Name: | OPMI TWINER SURGICAL MICROSCOPE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Scott A Margolin |
| Correspondent | Scott A Margolin 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 | 1998-11-02 |
| Decision Date | 1999-01-29 |
| Summary: | summary |