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FDA 510(k), K170305, Spinal Manometer NRFit; Spinal Manometer LUER
FDA 510(k), K170305, Spinal Manometer NRFit; Spinal Manometer LUER
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$49.00 USD
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$49.00 USD
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510(K) Number: K170305
Device Name: Spinal Manometer NRFit; Spinal Manometer LUER
Manufacturer: Christian G.H. Quass
Device Classification Name: Manometer, Spinal-Fluid
Regulation Number: FMJ
Classification Product Code: KXA
Date Received: 01/31/2017
Decision Date: 07/25/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Spinal Manometer NRFit; Spinal Manometer LUER
Manufacturer: Christian G.H. Quass
Device Classification Name: Manometer, Spinal-Fluid
Regulation Number: FMJ
Classification Product Code: KXA
Date Received: 01/31/2017
Decision Date: 07/25/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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