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510(k) K092192

WAYPOINT STEREOTACTIC SYSTEM by FHC, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2010
Date Received
July 21, 2009
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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