Customized Contour Implant

Prosthesis, Chin, Internal

Implantech Associates Inc.

The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Customized Contour Implant.

Pre-market Notification Details

Device IDK200610
510k NumberK200610
Device Name:Customized Contour Implant
ClassificationProsthesis, Chin, Internal
Applicant Implantech Associates Inc. 6025 Nicolle St., Suite B Ventura,  CA  93003
ContactCraig Arthur
CorrespondentPierre Bounaud
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodeFWP  
Subsequent Product CodeKKY
Subsequent Product CodeMIB
Subsequent Product CodeMIC
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-12-23

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