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510(k) K162219

CADD® Infusion Disposables Portfolio with NRFit™ connectors by Smiths Medical Asd, Inc. — Product Code PWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2017
Date Received
August 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Administrations Sets With Neuraxial Connectors
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

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