HIGH PROFILE 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 High Profile Chin Implant.

Pre-market Notification Details

Device IDK911516
510k NumberK911516
Device Name:HIGH PROFILE CHIN IMPLANT
ClassificationProsthesis, Chin, Internal
Applicant IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006
ContactDvorah A Richman
CorrespondentDvorah A Richman
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 Received1991-04-04
Decision Date1991-07-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724ACS1 K911516 000
M724ACM1 K911516 000
M724ACL1 K911516 000
M724ACXL1 K911516 000

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