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510(k) K121754

BLUE SUI SLING by Boston Scientific Corp — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2012
Date Received
June 14, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

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