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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.
 
Trade NameDERMABOND TOPICAL SKIN ADHESIVE
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametopical tissue adhesive
Regulation Number878.4010
ApplicantCLOSURE MEDICAL CORP.
PMA NumberP960052
Supplement NumberS012
Date Received08/16/2006
Decision Date09/14/2006
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the sterilization process.
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