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510(k) K191597

Stealth Autoguide System, Midas Rex Legend Depth Stop System by Medtronic Navigation, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2019
Date Received
June 17, 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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