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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K120243
Device Name GAM-200
Original Applicant
GC AMERICA INC.
3737 west 127th street
alsip,  IL  60803
Original Contact mark heiss
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/30/2012
Decision Date 06/27/2012
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 No
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