FUJI VII CAPSULE

Cement, Dental

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fuji Vii Capsule.

Pre-market Notification Details

Device IDK013198
510k NumberK013198
Device Name:FUJI VII CAPSULE
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 Received2001-09-25
Decision Date2001-10-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00386040009914 K013198 000
00386040009907 K013198 000
04548161077999 K013198 000
04548161077555 K013198 000

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