BINDER SUBMALAR FACIAL IMPLANT II

Implant, Malar

IMPLANTECH ASSOCIATES, INC.

The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Binder Submalar Facial Implant Ii.

Pre-market Notification Details

Device IDK895152
510k NumberK895152
Device Name:BINDER SUBMALAR FACIAL IMPLANT II
ClassificationImplant, Malar
Applicant IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
ContactEdward M Basile
CorrespondentEdward M Basile
IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
Product CodeLZK  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-10
Decision Date1989-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724BSMIIXL1 K895152 000
M724BSMIIS1 K895152 000
M724BSMIIM1 K895152 000
M724BSMIIL1 K895152 000

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