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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.
 
DeviceABSORBO HP-ABSORBABLE DUSTING POWDER
Generic NamePowder, dusting, surgical
ApplicantINGREDION INCORPORATED
10 FINDERNE AVENUE
SUITE C
BRIDGEWATER, NJ 08807
PMA NumberN80535
Supplement NumberS009
Date Received03/19/1999
Decision Date07/16/1999
Withdrawal Date 10/03/2013
Product Code KGP 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revised labeling. The request to replace the warning statement: "WARNING-The Powder Should Be Washed Off Gloves with Sterile Solution Before Treated Gloves Are Used In Surgery," with the statement: "Caution: After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method," is acceptable.
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