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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K172665
Device Name Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
Applicant
Wilson-Cook Medical, Inc. / Cook Endoscopy
4900 Bethania Station Road
Winston-Salem,  NC  27105
Applicant Contact Theresa de Prat
Correspondent
Wilson-Cook Medical, Inc. / Cook Endoscopy
4900 Bethania Station Road
Winston-Salem,  NC  27105
Correspondent Contact Theresa de Prat
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/05/2017
Decision Date 05/24/2018
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
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