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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 K081048
Device Name PINNACLE PELVIC FLOOR REPAIR KIT II
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough,  MA  01752
Contact michelle barry
Regulation Number878.3300
Classification Product Code
OTP  
Date Received04/14/2008
Decision Date 08/22/2008
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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