The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for S 22 Instrument Stand.
Device ID | K891584 |
510k Number | K891584 |
Device Name: | S 22 INSTRUMENT STAND |
Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Contact | Van Cader |
Correspondent | Van Cader CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Product Code | HRM |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-20 |
Decision Date | 1989-06-08 |