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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 (R)
Classification Namepowder, dusting, surgical
Generic Nameabsorbable dusting powder
Regulation Number878.4480
ApplicantGRAIN PROCESSING CORP.
PMA NumberP890070
Supplement NumberS003
Date Received08/18/1994
Decision Date01/27/1995
Product Code
KGP[ Registered Establishments with KGP ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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