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510(k) K181374

NRFit Syringe by Jiangsu Caina Medical Co.,Ltd — Product Code QEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2018
Date Received
May 24, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

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