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510(k) K080547

ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 by Aesculap Implant System, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2008
Date Received
February 28, 2008
Clearance Type
Special
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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