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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 NumberS009
Date Received08/19/2004
Decision Date09/24/2004
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional sterilization facility and to another known method of sterilization located at sterigenics (formerly iba/griffith), charlotte, north carolina.