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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, nose, internal
510(k) Number K871071
Device Name OMEGA DORSAL COLUMELLA IMPLANTS
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 Number878.3680
Classification Product Code
FZE  
Date Received03/18/1987
Decision Date 04/13/1987
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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