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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 stress urinary incontinence, retropubic or transobturator
510(k) Number K121754
Device Name BLUE SUI SLING
Original Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
m21
marlborough,  MA  01752
Original Contact janet a mcgrath
Regulation Number878.3300
Classification Product Code
OTN  
Date Received06/14/2012
Decision Date 10/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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