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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 Nametopical tissue adhesive
Regulation Number878.4010
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: sterilizer
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.