FUSION PUTTY TYPE

Material, Impression

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fusion Putty Type.

Pre-market Notification Details

Device IDK043493
510k NumberK043493
Device Name:FUSION PUTTY TYPE
ClassificationMaterial, Impression
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry Joritz
CorrespondentTerry Joritz
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-17
Decision Date2005-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10386040005821 K043493 000
10386040001519 K043493 000

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