The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for System 920 Argon/dye Photocoagulator.
| Device ID | K844357 |
| 510k Number | K844357 |
| Device Name: | SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR |
| 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 | 1985-06-05 |