The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for System 930 Argon Photocoagulator.
Device ID | K844356 |
510k Number | K844356 |
Device Name: | SYSTEM 930 ARGON PHOTOCOAGULATOR |
Classification | Photocoagulator And Accessories |
Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Contact | Theodore A Boutacof |
Correspondent | Theodore A Boutacof COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Product Code | HQB |
CFR Regulation Number | 886.4690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-09 |
Decision Date | 1985-05-16 |