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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 K222468
Device Name ArcTO Transobturator Sling System
Applicant
UroCure LLC
701 North 3rd Street, Suite 110
Minneapolis,  MN  55401
Applicant Contact John Nealon
Correspondent
Libra Medical Inc.
8401 73rd Avenue North,
Suite 63
Brooklyn Park,  MN  55428
Correspondent Contact Denise Lenz
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/16/2022
Decision Date 09/15/2022
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
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