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510(k) K132054

GYNECARE TVT EXACT CONTINENCE SYSTEM by Ethicon, Inc. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2013
Date Received
July 3, 2013
Clearance Type
Special
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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