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510(k) K871073

OMEGA BIVALVE NASAL SPLINTS by Omega Silicone, Inc. — Product Code FYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Facial Fracture, External
Device Class
Class I
Regulation Number
878.3250
Review Panel
SU
Submission Type

Other clearances by Omega Silicone, Inc.

  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871070 — OMEGA SILICONE CHIN IMPLANT (May 11, 1987)
  • K871071 — OMEGA DORSAL COLUMELLA IMPLANTS (April 13, 1987)
  • K871074 — OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR (April 10, 1987)

Other clearances for product code FYI

  • K821178 — ETHICON EXTERNAL FIXATION WIRE (June 11, 1983)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K792106 — CONPHAR O.R. HEAD COVER-STERILE (November 5, 1979)