EXTENDED CHIN IMPLANT STYLE II

Prosthesis, Chin, Internal

IMPLANTECH ASSOCIATES, INC.

The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Extended Chin Implant Style Ii.

Pre-market Notification Details

Device IDK902825
510k NumberK902825
Device Name:EXTENDED CHIN IMPLANT STYLE II
ClassificationProsthesis, Chin, Internal
Applicant IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
ContactEdward Basile
CorrespondentEdward Basile
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 Received1990-06-28
Decision Date1990-08-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724TEACM1 K902825 000
M724TEACXL1 K902825 000
M724CEACL1 K902825 000
M724CEACM1 K902825 000
M724CEACS1 K902825 000
M724CEACXL1 K902825 000
M724EACL1 K902825 000
M724EACM1 K902825 000
M724EACS1 K902825 000
M724EACXL1 K902825 000
M724TEACL1 K902825 000
M724TEACS1 K902825 000

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