FDA 510(k), K831678, P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR

FDA 510(k), K831678, P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR

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510(K) Number: K831678
Device Name: P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
Manufacturer:
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: KXA
Date Received: 05/23/1983
Decision Date: 06/24/1983
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
  • 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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