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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePURE-DENT B851 ABSORBABLE DUSTING POWDER
Classification Namepowder, dusting, surgical
Generic Namepowder, dusting, surgical
Regulation Number878.4480
Applicant
GRAIN PROCESSING CORP.
1600 oregon st.
muscatine, IA 52761
PMA NumberP890070
Supplement NumberS005
Date Received02/17/2011
Decision Date10/07/2011
Product Code
KGP
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at pacmoore process technologies, llc. In mooresville, indiana.
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