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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K170162
Device Name Vesco Medical Nasoenteric Feeding Tubes
Applicant
Vesco Medical, LLC
692 N. High St., Suite 205
Columbus,  OH  43215
Applicant Contact Chris O'Keefe
Correspondent
Vesco Medical, LLC
692 N. High St., Suite 205
Columbus,  OH  43215
Correspondent Contact Rachel Kunzweiler
Regulation Number876.5980
Classification Product Code
PIF  
Date Received01/18/2017
Decision Date 09/26/2017
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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