IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II

Prosthesis, Nose, Internal

IMPLANTECH ASSOCIATES, INC.

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

Pre-market Notification Details

Device IDK941960
510k NumberK941960
Device Name:IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
ClassificationProsthesis, Nose, Internal
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 CodeFZE  
CFR Regulation Number878.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-22
Decision Date1994-08-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724SNIL11 K941960 000
M724SNIL1PAK1 K941960 000
M724SNIL1NS1 K941960 000

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