The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Visulink 900 Argon.
| Device ID | K952894 |
| 510k Number | K952894 |
| Device Name: | VISULINK 900 ARGON |
| Classification | Laser, Ophthalmic |
| 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 | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-23 |
| Decision Date | 1995-08-14 |