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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K190084
Device Name McLean-Ring Enteral Feeding Tube Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Paul Meyer
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Paul Meyer
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/17/2019
Decision Date 10/11/2019
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
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