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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 K231891
Device Name Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Applicant
Coloplast
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Jennifer Mrkvicka
Correspondent
Coloplast
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Jennifer Mrkvicka
Regulation Number878.3300
Classification Product Code
OTM  
Subsequent Product Code
GAD  
Date Received06/27/2023
Decision Date 09/25/2023
Decision Substantially Equivalent - Kit (SESK)
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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