The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Visulas Argon Laser.
Device ID | K874609 |
510k Number | K874609 |
Device Name: | ZEISS VISULAS ARGON LASER |
Classification | Laser, 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 | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-09 |
Decision Date | 1988-01-06 |