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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K200247
Device Name Fusion Quattro Extraction Balloon
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Applicant Contact Tiffanny A Thomas
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Correspondent Contact Tiffanny A Thomas
Regulation Number876.5010
Classification Product Code
GCA  
Date Received01/31/2020
Decision Date 02/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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