K770959 is an FDA 510(k) clearance for the BOUGIE, FILIFORM, JACKSON. This device is classified as a Bougie, Eustachian (Class I - General Controls, product code KBI).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1977, 18 days after receiving the submission on May 27, 1977.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4175.
| 510(k) Number | K770959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 1977 |
| Decision Date | June 14, 1977 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | KBI — Bougie, Eustachian |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4175 |