FDA 510(k) Application Details - K100423

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K100423
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant ETHICON, INC.
PO BOX 151, ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
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Contact NEELU MEDHEKAR
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 02/16/2010
Decision Date 05/04/2010
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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