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510(k) K083378

SYNERGY by Innerspace, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2009
Date Received
November 14, 2008
Clearance Type
Special
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

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  • K010422 — ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER (June 28, 2001)
  • K003905 — ACTI-ICP MONITORING SYSTEM (June 15, 2001)

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