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510(k) K071697

NEURONAV SYSTEM AND NEURONAV DRIVE by Alpha Omega , Ltd. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2007
Date Received
June 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

Other clearances by Alpha Omega , Ltd.

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  • K993622 — NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY (January 24, 2000)

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