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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K122816
Device Name AXCESS SOFT TIP WIRE GUIDE
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Applicant Contact DORIS A HAWKS
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Correspondent Contact DORIS A HAWKS
Regulation Number876.1500
Classification Product Code
OCY  
Date Received09/14/2012
Decision Date 10/09/2012
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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