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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ear, Internal
510(k) Number K172389
Device Name ePTFE-Coated Auricular Implant
Applicant
Implantech Associates, Inc.
6025 Nicolle St., Suite B
Ventura,  CA  93003
Applicant Contact Craig Arthur
Correspondent
Acknowledge Regulatory Strategies, LLC
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number878.3590
Classification Product Code
FZD  
Subsequent Product Codes
FWP   FZE   LZK  
Date Received08/08/2017
Decision Date 07/18/2018
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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