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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 K192339
Device Name TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Applicant Contact Marge Walls-Walker
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Correspondent Contact Marge Walls-Walker
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/28/2019
Decision Date 01/30/2020
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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