TRAPEZOIDAL MALAR IMPLANT

Implant, Malar

IMPLANTECH ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK911513
510k NumberK911513
Device Name:TRAPEZOIDAL MALAR IMPLANT
ClassificationImplant, Malar
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 CodeLZK  
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
M724TM41 K911513 000
M724TM31 K911513 000
M724TM21 K911513 000
M724TM51 K911513 000
M724TM11 K911513 000

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