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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 NumberS005
Date Received06/27/2002
Decision Date07/24/2002
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in indications to clarify the use of the device.
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