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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 K053361
Device Name MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
Applicant
Mpathy Medical Devices, Ltd.
150 Aran Hill Rd.
Fairfield,  CT  06824 -1712
Applicant Contact LOUIS J MAZZARESE
Correspondent
Mpathy Medical Devices, Ltd.
150 Aran Hill Rd.
Fairfield,  CT  06824 -1712
Correspondent Contact LOUIS J MAZZARESE
Regulation Number878.3300
Classification Product Code
OTO  
Subsequent Product Code
OTP  
Date Received12/02/2005
Decision Date 02/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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