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510(k) K152764

EXACTECH GPS by Blue Ortho — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2016
Date Received
September 24, 2015
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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