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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
Original Applicant
MPATHY MEDICAL DEVICES, LTD.
150 aran hill road
fairfield,  CT  06824 1712
Original 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 (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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