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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHALLMARK ABSORBO ABSORBABLE DUSTING POWDER
Generic NamePowder, dusting, surgical
ApplicantIngredion Incorporated
10 Finderne Ave.
Suite C
Bridgewater, NJ 08807
PMA NumberN80535
Supplement NumberS006
Date Received05/22/1990
Decision Date09/19/1990
Withdrawal Date10/03/2013
Product Code KGP 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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