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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 K103426
Device Name LITE PELVIC FLOOR REPAIR KITS
Original Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough,  MA  01752
Original Contact michelle berry
Regulation Number878.3300
Classification Product Code
OTP  
Date Received11/22/2010
Decision Date 09/14/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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