The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Bougie, Filiform, Jackson.
| Device ID | K770959 |
| 510k Number | K770959 |
| Device Name: | BOUGIE, FILIFORM, JACKSON |
| Classification | Bougie, Eustachian |
| Applicant | V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KBI |
| CFR Regulation Number | 874.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-27 |
| Decision Date | 1977-06-14 |