GC FUJI LINING LC PASTE PAK

Cement, Dental

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Lining Lc Paste Pak.

Pre-market Notification Details

Device IDK020117
510k NumberK020117
Device Name:GC FUJI LINING LC PASTE PAK
ClassificationCement, Dental
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry L Joritz
CorrespondentTerry L Joritz
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-14
Decision Date2002-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10386040009201 K020117 000

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