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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 K142297
Device Name Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
Applicant
XERIDIEM (FORMERLY MRI)
4700 S. OVERLAND DR.
TUCSON,  AZ  85714
Applicant Contact Jesus Valencia
Correspondent
XERIDIEM (FORMERLY MRI)
4700 S. OVERLAND DR.
TUCSON,  AZ  85714
Correspondent Contact Jesus Valencia
Regulation Number876.5980
Classification Product Code
PIF  
Date Received08/18/2014
Decision Date 01/08/2015
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 Yes
Recalls CDRH Recalls
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