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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K141027
Device Name 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
Applicant
Implantech Associates, Inc.
6025 Nicolle St., Suite B
Ventura,  CA  93003
Applicant Contact STEPHEN MEADE
Correspondent
Implantech Associates, Inc.
6025 Nicolle St., Suite B
Ventura,  CA  93003
Correspondent Contact STEPHEN MEADE
Regulation Number878.3550
Classification Product Code
FWP  
Subsequent Product Codes
FZE   LZK  
Date Received04/22/2014
Decision Date 07/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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