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510(k) K871074

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR by Omega Silicone, Inc. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Omega Silicone, Inc.

  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871073 — OMEGA BIVALVE NASAL SPLINTS (May 11, 1987)
  • K871070 — OMEGA SILICONE CHIN IMPLANT (May 11, 1987)
  • K871071 — OMEGA DORSAL COLUMELLA IMPLANTS (April 13, 1987)

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