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510(k) K051746

ELEKTA ESARTE FRAME SYSTEM by Elekta Instrument AB — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2005
Date Received
June 29, 2005
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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