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510(k) K212397

StealthStation S8 Cranial v2.0 by Medtronic Navigation — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
August 2, 2021
Clearance Type
Traditional
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

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