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510(k) K190026

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) by Teleflex Medical — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2019
Date Received
January 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

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