The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss 20 Sl Slit-lamp & Mechanical Micromanipulatr.
Device ID | K925641 |
510k Number | K925641 |
Device Name: | ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
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 | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-09 |
Decision Date | 1993-09-09 |