The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Coherent Marie Argon Photocoagulator.
Device ID | K893709 |
510k Number | K893709 |
Device Name: | COHERENT MARIE ARGON PHOTOCOAGULATOR |
Classification | Laser, Ophthalmic |
Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Contact | Virginia Singer |
Correspondent | Virginia Singer COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-18 |
Decision Date | 1989-06-15 |