FIT CHECKER ADVANCED

Material, Impression

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fit Checker Advanced.

Pre-market Notification Details

Device IDK110871
510k NumberK110871
Device Name:FIT CHECKER ADVANCED
ClassificationMaterial, Impression
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactMark Heiss
CorrespondentMark Heiss
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 Received2011-03-29
Decision Date2011-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14548161297257 K110871 000
14548161282437 K110871 000

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