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510(k) K013396

ALPHA DRIVE SYSTEM by Alpha Omega , Ltd. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2002
Date Received
October 15, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
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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