K770054 is an FDA 510(k) clearance for the MIRROR, NASO-PHARYNX. This device is classified as a Mirror, Ent (Class I - General Controls, product code KAI).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1977, 8 days after receiving the submission on January 10, 1977.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K770054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1977 |
| Decision Date | January 18, 1977 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | KAI — Mirror, Ent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |