Submission Details
| 510(k) Number | K770959 FDA.gov |
| FDA Decision | Cleared 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 | — |
Cleared
Traditional
K770959 - BOUGIE, FILIFORM, JACKSON
(FDA 510(k) Clearance)
Jun 1977
Decision
18d
Days
Class 1
Risk
K770959 is an FDA 510(k) clearance for the BOUGIE, FILIFORM, JACKSON, 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 review panel. Regulated under 21 CFR 874.4175.
Device Classification
| Product Code | KBI — Bougie, Eustachian |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 874.4175 |