K860975 is an FDA 510(k) clearance for the MODEL 545-45 LASER FOR EAR, NOSE & THROAT. This device is classified as a Laser, Ent Microsurgical Carbon-dioxide (Class II - Special Controls, product code EWG).
Submitted by Britt Corp., Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 18, 1986, 126 days after receiving the submission on March 14, 1986.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K860975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1986 |
| Decision Date | July 18, 1986 |
| Days to Decision | 126 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 |