FDA 510(k), K172823, Portex NRFit Epidural Needles
FDA 510(k), K172823, Portex NRFit Epidural Needles
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510(K) Number: K172823
Device Name: Portex NRFit Epidural Needles
Manufacturer: Sunita Teekasingh
Device Classification Name: Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation Number: BSP
Classification Product Code: 09/18/2017
Date Received: 06/12/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Portex NRFit Epidural Needles
Manufacturer: Sunita Teekasingh
Device Classification Name: Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation Number: BSP
Classification Product Code: 09/18/2017
Date Received: 06/12/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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