K852695 is an FDA 510(k) clearance for the FOR USE IN EAR; NOSE & THROAT MICROSURGERY. This device is classified as a Laser, Ent Microsurgical Carbon-dioxide (Class II - Special Controls, product code EWG).
Submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on August 30, 1985, 65 days after receiving the submission on June 26, 1985.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K852695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1985 |
| Decision Date | August 30, 1985 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWG — Laser, Ent Microsurgical Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4500 |