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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 Apical Vaginal And Uterine Prolapse, Transabdominally Placed
510(k) Number K041632
Device Name MINIMESH POLYPROPYLENE MESH
Applicant
Mpathy Medical Devices, Ltd.
150 Aran Hill Rd.
Farfield,  CT  06824
Applicant Contact LOUIS J MAZZARESE
Correspondent
Mpathy Medical Devices, Ltd.
150 Aran Hill Rd.
Farfield,  CT  06824
Correspondent Contact LOUIS J MAZZARESE
Regulation Number878.3300
Classification Product Code
OTO  
Subsequent Product Code
OTP  
Date Received06/16/2004
Decision Date 11/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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