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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, esophageal
510(K) Number K121505
Device Name DISPOSABLE HEMOSTASIS CHIP
Applicant
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
4900 bethania station road
winston-salem,  NC  27105
Contact scottie fariole
Regulation Number876.4400
Classification Product Code
MND  
Date Received05/21/2012
Decision Date 08/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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