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510(k) K131154

ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; by Zevex, Inc. — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2014
Date Received
April 24, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Enteral
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K040957 — NOA III ENTERAL NUTRITION PUMP (May 21, 2004)