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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received12/20/1989
Decision Date08/10/1990
Product Code
KGP[ Registered Establishments with KGP ]
Docket Number 90M-0273
Notice Date 10/01/1990
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 
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