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510(k) K221087

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 by Medtronic Navigation, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2022
Date Received
April 13, 2022
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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