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Omega Silicone Chin Implant

by Omega Silicone, Inc. 510(k)

Active United States

510(k) K871070

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871070 Date11 May 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FWP
Device Class
Class II
Regulation
21 CFR Part 878.3550
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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