The following data is part of a premarket notification filed by Cooper Medical Corp. with the FDA for Monitor Co2 Laser System.
| Device ID | K820261 |
| 510k Number | K820261 |
| Device Name: | MONITOR CO2 LASER SYSTEM |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | COOPER MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1982-03-05 |