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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, facial fracture, external
510(k) Number K871073
Device Name OMEGA BIVALVE NASAL SPLINTS
Applicant
OMEGA SILICONE, INC.
725 YANONALI
SANTA BARBARA,  CA  93103
Applicant Contact OLE JOHANSSON
Correspondent
OMEGA SILICONE, INC.
725 YANONALI
SANTA BARBARA,  CA  93103
Correspondent Contact OLE JOHANSSON
Regulation Number878.3250
Classification Product Code
FYI  
Date Received03/18/1987
Decision Date 05/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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