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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tissue adhesive for the topical approximation of skin
510(k) Number K121976
Device Name AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley,  PA  18034
Original Contact kathy a racosky
Regulation Number878.4010
Classification Product Code
MPN  
Date Received07/05/2012
Decision Date 05/17/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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