EXAJET

Material, Impression

GC AMERICA, INC.

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

Pre-market Notification Details

Device IDK023751
510k NumberK023751
Device Name:EXAJET
ClassificationMaterial, Impression
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 CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-08
Decision Date2003-01-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10386040005678 K023751 000
10386040005661 K023751 000
10386040005654 K023751 000
10386040005647 K023751 000
10386040005630 K023751 000
10386040005623 K023751 000

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