FDA 510(k) Application Details - K111959

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K111959
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact KATHY A RACOSKY
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 07/11/2011
Decision Date 02/06/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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