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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 K941960
Device Name IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
Applicant
Implantech Associates, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact EDWARD M BASILE
Correspondent
Implantech Associates, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact EDWARD M BASILE
Regulation Number878.3680
Classification Product Code
FZE  
Date Received04/22/1994
Decision Date 08/17/1994
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
Predetermined Change
Control Plan Authorized		 No
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