FDA 510(k) Application Details - K133443

Device Classification Name Bandage, Liquid

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510(K) Number K133443
Device Name Bandage, Liquid
Applicant ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON PL7 5BG GB
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Contact ROSE GUANG
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 11/12/2013
Decision Date 07/10/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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