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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
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 Received06/17/2004
Decision Date 11/17/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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