The following data is part of a premarket notification filed by Santa Barbara Medco, Inc. with the FDA for Nasal Septal Button.
| Device ID | K850492 |
| 510k Number | K850492 |
| Device Name: | NASAL SEPTAL BUTTON |
| Classification | Button, Nasal Septal |
| Applicant | SANTA BARBARA MEDCO, INC. P.O. BOX 6843 Santa Barbara, CA 93111 |
| Contact | David G Esslinger |
| Correspondent | David G Esslinger SANTA BARBARA MEDCO, INC. P.O. BOX 6843 Santa Barbara, CA 93111 |
| Product Code | LFB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-08 |
| Decision Date | 1985-03-07 |