K820261 is an FDA 510(k) clearance for the MONITOR CO2 LASER SYSTEM. This device is classified as a Laser, Surgical, Gynecologic (Class II - Special Controls, product code HHR).
Submitted by Cooper Medical Corp. (Walker, US). The FDA issued a Cleared decision on March 5, 1982, 31 days after receiving the submission on February 2, 1982.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K820261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1982 |
| Decision Date | March 05, 1982 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHR — Laser, Surgical, Gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4550 |