The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss 30 Sl-l.
Device ID | K862004 |
510k Number | K862004 |
Device Name: | ZEISS 30 SL-L |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Contact | Marie Pederson |
Correspondent | Marie Pederson CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-27 |
Decision Date | 1986-06-17 |