FDA 510(k) Application Details - K110184

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K110184
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant MEDLOGIC GLOBAL LIMITED
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON PL7 5BG GB
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Contact MICHAEL BROWNE
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 01/21/2011
Decision Date 12/16/2011
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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