FDA 510(k) Application Details - K200610

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K200610
Device Name Prosthesis, Chin, Internal
Applicant Implantech Associates Inc.
6025 Nicolle St., Suite B
Ventura, CA 93003 US
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Contact Craig Arthur
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Regulation Number 878.3550

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Classification Product Code FWP
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Date Received 03/09/2020
Decision Date 12/23/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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