The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for S 21 Instrument Stand.
Device ID | K883578 |
510k Number | K883578 |
Device Name: | S 21 INSTRUMENT STAND |
Classification | Tray, Surgical, Needle |
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 | FSH |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-22 |
Decision Date | 1988-09-13 |