The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Ziess Endoprobe.
Device ID | K922735 |
510k Number | K922735 |
Device Name: | ZIESS ENDOPROBE |
Classification | Photocoagulator And Accessories |
Applicant | CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
Contact | Christopher Talbot |
Correspondent | Christopher Talbot CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
Product Code | HQB |
CFR Regulation Number | 886.4690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-08 |
Decision Date | 1992-07-09 |