FDA 510(k) Application Details - K091180

Device Classification Name

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510(K) Number K091180
Device Name MINITAPE URETHRAL SLING
Applicant MPATHY MEDICAL DEVICES, LTD.
LONMAY ROAD
QUEENSLIE
GLASGOW G33 4EL GB
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Contact CAROLINE STRETTON
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Regulation Number

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Classification Product Code PAH
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Date Received 04/23/2009
Decision Date 07/14/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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