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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K171596
Device Name ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
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 Number876.1075
Classification Product Code
FCG  
Date Received05/31/2017
Decision Date 08/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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