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510(k) K032337

HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 by Hemedex Incorporated — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2003
Date Received
July 29, 2003
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

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