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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.
 
Trade NamePURE-DENT B851 ABSORBABLE DUSTING POWDER
Classification Namepowder, dusting, surgical
Generic Nameabsorbable dusting powder
Regulation Number878.4480
ApplicantGRAIN PROCESSING CORP.
PMA NumberP890070
Supplement NumberS005
Date Received02/17/2011
Decision Date10/07/2011
Product Code
KGP[ Registered Establishments with KGP ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
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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