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510(k) K993622

NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY by Alpha Omega , Ltd. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2000
Date Received
October 26, 1999
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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  • K001520 — ALPHA OMEGA DUAL COOLER-HEATER (November 22, 2000)

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