FDA 510(k) Application Details - K103805

Device Classification Name Device, Specimen Collection

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510(K) Number K103805
Device Name Device, Specimen Collection
Applicant MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
POTLEY LANE
CORSHAM, WILTSHIRE SN13 9RT GB
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Contact DAVID ELLIS
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Regulation Number 866.2900

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Classification Product Code LIO
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Date Received 12/28/2010
Decision Date 01/25/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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