The following data is part of a premarket notification filed by Cooper Medical Corp. with the FDA for Cooper Medical Model 770.
| Device ID | K833497 |
| 510k Number | K833497 |
| Device Name: | COOPER MEDICAL MODEL 770 |
| Classification | Laser, Neurosurgical, Argon |
| Applicant | COOPER MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LLF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-11 |
| Decision Date | 1984-04-17 |