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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saliva, artificial
510(k) Number K101346
FOIA Releasable 510(k) K101346
Device Name GC ORAL MOISTURIZING GEL
Applicant
GC AMERICA, INC.
3737 W. 127TH ST.
ALSIP,  IL  60803
Applicant Contact MARK HEISS
Correspondent
GC AMERICA, INC.
3737 W. 127TH ST.
ALSIP,  IL  60803
Correspondent Contact MARK HEISS
Classification Product Code
LFD  
Date Received05/13/2010
Decision Date 01/27/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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