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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, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
510(k) Number K183134
Device Name ArcTV Transvaginal Sling System
Applicant
UroCure LLC
4701 North 3rd Street, Suite 110
Minneapolis,  MN  55401
Applicant Contact John Nealon
Correspondent
Libra Medical Inc
8401 73rd Ave N, Suite 63
Brooklyn Park,  MN  55428
Correspondent Contact Ming Cheng Chew
Regulation Number878.3300
Classification Product Code
OTN  
Date Received11/13/2018
Decision Date 02/07/2019
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
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