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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.
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametissue adhesive for the topical approximation of skin
Regulation Number878.4010
5265 capital blvd.
raleigh, NC 27616
PMA NumberP960052
Supplement NumberS003
Date Received04/10/2001
Decision Date11/19/2001
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a statement in the labeling that the deivce provides microbial barrier properties.