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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameHISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
Classification Nametissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantTISSUE SEAL LLC
PMA NumberP050013
Date Received03/25/2005
Decision Date02/16/2007
Reclassified Date 05/05/2008
Product Code
MPN[ Registered Establishments with MPN ]
Docket Number 07M-0086
Notice Date 03/16/2007
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the histoacryl and histoacryl blue topical skin adhesive. The device is indicated for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl and histoacryl blue topical skin adhesive may be used in conjunction with but not in place of dermal sutures.
Approval Order Approval Order
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