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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, Retropubic Or Transobturator
510(k) Number K073647
Device Name MINITAPE EXTRA URETHRAL SLING
Applicant
Mpathy Medical Devices, Ltd.
24 Barberry Ln.
Madison,  CT  06443
Applicant Contact LOUIS J MAZZARESE
Correspondent
Mpathy Medical Devices, Ltd.
24 Barberry Ln.
Madison,  CT  06443
Correspondent Contact LOUIS J MAZZARESE
Regulation Number878.3300
Classification Product Code
OTN  
Date Received12/26/2007
Decision Date 03/03/2008
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
Predetermined Change
Control Plan Authorized		 No
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