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510(k) K190672

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 by Medtronic Navigation, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2019
Date Received
March 15, 2019
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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