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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K182319
Device Name Glo-Tip Spray Catheter
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Applicant Contact Paula Joyce
Correspondent
MED Institute
1330 Win Hentschel Boulevard
West Lafayette,  IN  47906
Correspondent Contact Daniel J. Dillon
Regulation Number876.1500
Classification Product Code
OCX  
Date Received08/27/2018
Decision Date 02/01/2019
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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