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510(k) K142344

DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System by Izi Medical Products, LLC — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
August 22, 2014
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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