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510(k) K141869

QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT by Hemedex Incorporated — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2014
Date Received
July 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

Other clearances by Hemedex Incorporated

  • K032127 — HEMEDEX FIXATION DEVICE (December 30, 2003)
  • K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 (October 21, 2003)
  • K013376 — QFLOW 500 PERFUSION MONITORING SYSTEM (May 8, 2002)

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