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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
510(k) Number K073646
Device Name MINITAPE URETHRAL SLING
Applicant
MPATHY MEDICAL DEVICES, LTD.
24 BARBERRY LANE
MADISON,  CT  06443
Applicant Contact LOUIS J MAZZARESE
Correspondent
MPATHY MEDICAL DEVICES, LTD.
24 BARBERRY LANE
MADISON,  CT  06443
Correspondent Contact LOUIS J MAZZARESE
Regulation Number878.3300
Classification Product Code
PAH  
Date Received12/26/2007
Decision Date 02/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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