K895738 is an FDA 510(k) clearance for the MICROMEDICS EAR, NOSE AND THROAT BURS. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 19, 1989, 84 days after receiving the submission on September 26, 1989.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.
| 510(k) Number | K895738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1989 |
| Decision Date | December 19, 1989 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EQJ — Bur, Ear, Nose And Throat |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4140 |