OMEGA DORSAL COLUMELLA IMPLANTS— 510(k) K871071

Name: FDA 510(k) clearance K871071
Creator: U.S. Food and Drug Administration
Published: 1987-04-13

Substantially Equivalent

Omega Silicone, Inc.

FDA 510(k) clearance K871071 for OMEGA DORSAL COLUMELLA IMPLANTS, Substantially Equivalent on 1987-04-13. Applicant: Omega Silicone, Inc.. Device class: 2.

Clearance details

Applicant: Omega Silicone, Inc.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 1987-03-18
Decision date: 1987-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Omega Silicone, Inc.

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K871072 — OMEGA NASAL SEPTAL BUTTON1987-06-08
K871070 — OMEGA SILICONE CHIN IMPLANT1987-05-11
K871073 — OMEGA BIVALVE NASAL SPLINTS1987-05-11
K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR1987-04-10

Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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