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FDA 510(k), K172800, Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
FDA 510(k), K172800, Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
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$149.00 USD
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510(K) Number: K172800
Device Name: Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
Manufacturer: Michael R. Johnson
Device Classification Name: Needle, Spinal, Short Term
Regulation Number: MIA
Classification Product Code: 09/18/2017
Date Received: 06/14/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
Manufacturer: Michael R. Johnson
Device Classification Name: Needle, Spinal, Short Term
Regulation Number: MIA
Classification Product Code: 09/18/2017
Date Received: 06/14/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- 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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