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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K111895
Device Name ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
Applicant
Wilson-Cook Medical Inc./Cook Endoscopy
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Applicant Contact MARGE WALLS-WALKER
Correspondent
Wilson-Cook Medical Inc./Cook Endoscopy
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Correspondent Contact MARGE WALLS-WALKER
Regulation Number878.4300
Classification Product Code
NEU  
Subsequent Product Code
FCG  
Date Received07/05/2011
Decision Date 04/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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