FDA 510(k) Application Details - K073646

Device Classification Name

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510(K) Number K073646
Device Name MINITAPE URETHRAL SLING
Applicant MPATHY MEDICAL DEVICES, LTD.
24 BARBERRY LANE
MADISON, CT 06443 US
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Contact LOUIS J MAZZARESE
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Regulation Number

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Classification Product Code PAH
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Date Received 12/26/2007
Decision Date 02/25/2008
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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