The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for System 920 Photocoagulator To Include Schirmerscop.
Device ID | K844358 |
510k Number | K844358 |
Device Name: | SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP |
Classification | Laser, Ophthalmic |
Applicant | COHERENT MEDICAL GROUP 4221 Richmond Rd., N.W. Walker, MI 49534 |
Contact | Theodore A Boutacof |
Correspondent | Theodore A Boutacof COHERENT MEDICAL GROUP 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-09 |
Decision Date | 1985-01-03 |