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510(k) K111881

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT by Coloplast A/S — Product Code OTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2011
Date Received
July 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

surgical treatment of male stress urinary incontinence post-prostatectomy

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  • K063079 — I-STOP TRANS OBTURATOR MALE SLING (November 7, 2006)
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