OMEGA BIVALVE NASAL SPLINTS— 510(k) K871073

Name: FDA 510(k) clearance K871073
Creator: U.S. Food and Drug Administration
Published: 1987-05-11

Substantially Equivalent

Omega Silicone, Inc.

FDA 510(k) clearance K871073 for OMEGA BIVALVE NASAL SPLINTS, Substantially Equivalent on 1987-05-11. Applicant: Omega Silicone, Inc.. Device class: 1.

Clearance details

Applicant: Omega Silicone, Inc.
Product code: Code FYI
Device class: Class 1
Regulation: 21 CFR 878.3250
Advisory panel: General, Plastic Surgery
Date received: 1987-03-18
Decision date: 1987-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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K801072 — STRAITH NASAL SPLINT1980-06-17
K792106 — CONPHAR O.R. HEAD COVER-STERILE1979-11-05

More clearances from Omega Silicone, Inc.

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K871072 — OMEGA NASAL SEPTAL BUTTON1987-06-08
K871070 — OMEGA SILICONE CHIN IMPLANT1987-05-11
K871071 — OMEGA DORSAL COLUMELLA IMPLANTS1987-04-13
K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR1987-04-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.