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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 K192991
Device Name Vesco Medical Extension Feeding Set
Applicant
Vesco Medical LLC
1039 Kingsmill Pkwy
Columbus,  OH  43229
Applicant Contact Chris O'Keefe
Correspondent
Vesco Medical LLC
1039 Kingsmill Pkwy
Columbus,  OH  43229
Correspondent Contact Chris O'Keefe
Regulation Number876.5980
Classification Product Code
PIF  
Date Received10/25/2019
Decision Date 08/03/2020
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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