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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, For Stress Urinary Incontinence, Male
510(k) Number K113496
Device Name VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
Applicant
COLOPLAST A/S
1601 WEST RIVER RD NORTH
MINNEAPOLIS,  MN  55411
Applicant Contact JANELL COLLEY
Correspondent
COLOPLAST A/S
1601 WEST RIVER RD NORTH
MINNEAPOLIS,  MN  55411
Correspondent Contact JANELL COLLEY
Regulation Number878.3300
Classification Product Code
OTM  
Subsequent Product Code
GAD  
Date Received11/25/2011
Decision Date 02/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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