CURVILINEAR SILICONE CHIN 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 Curvilinear Silicone Chin Implant.

Pre-market Notification Details

Device IDK902941
510k NumberK902941
Device Name:CURVILINEAR SILICONE CHIN IMPLANT
ClassificationProsthesis, Chin, Internal
Applicant IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
ContactEdward M Basile,esq
CorrespondentEdward M Basile,esq
IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
Product CodeFWP  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-03
Decision Date1990-08-02

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