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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 K150084
Device Name Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact SONA MANICKAM
Correspondent
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact SONA MANICKAM
Regulation Number876.5980
Classification Product Code
PIF  
Date Received01/15/2015
Decision Date 07/13/2015
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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