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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 K904657
Device Name FLOWERS DORSAL COLUMELLA IMPLANT
Applicant
IMPLANTECH ASSOCIATES, INC.
1730 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Applicant Contact M BASILE
Correspondent
IMPLANTECH ASSOCIATES, INC.
1730 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Correspondent Contact M BASILE
Regulation Number878.3680
Classification Product Code
FZE  
Date Received10/15/1990
Decision Date 12/18/1990
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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