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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 K200610
Device Name Customized Contour Implant
Applicant
Implantech Associates Inc.
6025 Nicolle St., Suite B
Ventura,  CA  93003
Applicant Contact Craig Arthur
Correspondent
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Pierre Bounaud
Regulation Number878.3550
Classification Product Code
FWP  
Subsequent Product Codes
KKY   MIB   MIC  
Date Received03/09/2020
Decision Date 12/23/2020
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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