G-CERA ORBIT COLOUR COMMUNICATION SET

Powder, Porcelain

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-cera Orbit Colour Communication Set.

Pre-market Notification Details

Device IDK932039
510k NumberK932039
Device Name:G-CERA ORBIT COLOUR COMMUNICATION SET
ClassificationPowder, Porcelain
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 CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-27
Decision Date1993-07-08

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