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510(k) K080250

LEKSELL SURGIPLAN, MODEL 1006947 by Elekta Instrument AB — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2008
Date Received
January 31, 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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