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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 K230326
Device Name ENFit to ENFit Extension Sets
Applicant
Vesco Medical
60 Collegeview Road, Suite 144
Westerville,  OH  43081
Applicant Contact Chris O'Keefe
Correspondent
Vesco Medical
60 Collegeview Road, Suite 144
Westerville,  OH  43081
Correspondent Contact Glenn Brunner
Regulation Number876.5980
Classification Product Code
PIF  
Date Received02/06/2023
Decision Date 11/02/2023
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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