GC AADVA ZR DISK

Powder, Porcelain

GC AMERICA, INC.

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

Pre-market Notification Details

Device IDK082740
510k NumberK082740
Device Name:GC AADVA ZR DISK
ClassificationPowder, Porcelain
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 CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-18
Decision Date2008-11-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EKLE8781211 K082740 000
EKLE8781231 K082740 000
EKLE8781241 K082740 000
EKLE8781251 K082740 000
EKLE8781141 K082740 000
EKLE8781151 K082740 000
EKLE8781161 K082740 000
EKLE8781171 K082740 000
EKLE8781181 K082740 000
EKLE8781191 K082740 000
EKLE8781201 K082740 000
EKLE8781221 K082740 000

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