OMEGA SILICONE CHIN IMPLANT— 510(k) K871070

Name: FDA 510(k) clearance K871070
Creator: U.S. Food and Drug Administration
Published: 1987-05-11

Substantially Equivalent

Omega Silicone, Inc.

FDA 510(k) clearance K871070 for OMEGA SILICONE CHIN IMPLANT, Substantially Equivalent on 1987-05-11. Applicant: Omega Silicone, Inc.. Device class: 2.

Clearance details

Applicant: Omega Silicone, Inc.
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
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 ↗

Recent devices under product code FWP

view all

K254233 — MEDPOR Customized Implant Kit2026-03-12
K232593 — FITme Customized Silicone Implant2023-11-22
K200610 — Customized Contour Implant2020-12-23
K191130 — Customized Contour Implant2019-08-23
K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit2019-08-15

More clearances from Omega Silicone, Inc.

view all

K871072 — OMEGA NASAL SEPTAL BUTTON1987-06-08
K871073 — OMEGA BIVALVE NASAL SPLINTS1987-05-11
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.