FDA 510(k) Application Details - K132243

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K132243
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON PL7 5BG GB
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Contact KAY MCGRATH
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 07/18/2013
Decision Date 12/20/2013
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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