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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K121505
Device Name DISPOSABLE HEMOSTASIS CHIP
Applicant
Wilson-Cook Medical Inc./Cook Endoscopy
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Applicant Contact SCOTTIE FARIOLE
Correspondent
Wilson-Cook Medical Inc./Cook Endoscopy
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Correspondent Contact SCOTTIE FARIOLE
Regulation Number876.4400
Classification Product Code
PKL  
Date Received05/21/2012
Decision Date 08/31/2012
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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