Submission Details
| 510(k) Number | K871073 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 18, 1987 |
| Decision Date | May 11, 1987 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
K871073 - OMEGA BIVALVE NASAL SPLINTS
(FDA 510(k) Clearance)
May 1987
Decision
54d
Days
Class 1
Risk
K871073 is an FDA 510(k) clearance for the OMEGA BIVALVE NASAL SPLINTS, a Appliance, Facial Fracture, External (Class I — General Controls, product code FYI), submitted by Omega Silicone, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on May 11, 1987, 54 days after receiving the submission on March 18, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3250.
Device Classification
| Product Code | FYI — Appliance, Facial Fracture, External |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.3250 |
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