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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name varnish, cavity
510(k) Number K102808
Device Name MI VARNISH
Original Applicant
GC AMERICA INC.
3737 west 127th street
alsip,  IL  60803
Original Contact mark heiss
Regulation Number872.3260
Classification Product Code
LBH  
Date Received09/28/2010
Decision Date 12/22/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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