The following data is part of a premarket notification filed by Omega Silicone, Inc. with the FDA for Omega Bivalve Nasal Splints.
| Device ID | K871073 |
| 510k Number | K871073 |
| Device Name: | OMEGA BIVALVE NASAL SPLINTS |
| Classification | Appliance, Facial Fracture, External |
| Applicant | OMEGA SILICONE, INC. 725 YANONALI Santa Barbara, CA 93103 |
| Contact | Ole Johansson |
| Correspondent | Ole Johansson OMEGA SILICONE, INC. 725 YANONALI Santa Barbara, CA 93103 |
| Product Code | FYI |
| CFR Regulation Number | 878.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-05-11 |