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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 K101297
Device Name VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
Applicant
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact ANGELA BYLAND
Correspondent
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact ANGELA BYLAND
Regulation Number878.3300
Classification Product Code
OTM  
Date Received05/10/2010
Decision Date 06/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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