K955704 is an FDA 510(k) clearance for the TREBAY MICRODEBRIDER SYSTEM. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).
Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on January 30, 1996, 46 days after receiving the submission on December 15, 1995.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.
| 510(k) Number | K955704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1995 |
| Decision Date | January 30, 1996 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EQJ — Bur, Ear, Nose And Throat |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4140 |