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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 K142539
Device Name EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
Applicant
Zevex, Inc.
4314 Zevex Park Ln.
Salt Lake City,  UT  84123
Applicant Contact Dianne Batch
Correspondent
Zevex, Inc.
4314 Zevex Park Ln.
Salt Lake City,  UT  84123
Correspondent Contact Dianne Batch
Regulation Number876.5980
Classification Product Code
PIF  
Date Received09/09/2014
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 No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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