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FDA 510(k) Application Details - K111959
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4010
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Classification Product Code
MPN
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More FDA Info for this Product Code
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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