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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 pelvic organ prolapse, transvaginally placed
510(k) Number K091131
Device Name PELVIC FLOOR REPAIR SYSTEM
Original Applicant
BOSTONSCIENTIFIC
100 boston scientific way
marlborough,  MA  01752
Original Contact michelle berry
Regulation Number878.3300
Classification Product Code
OTP  
Date Received04/20/2009
Decision Date 05/08/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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