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FDA 510(k) Application Details - K080250
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K080250
Device Name
Neurological Stereotaxic Instrument
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
P.O.BOX 7593
STOCKHOLM S-103 93 SE
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Contact
PETER LOWENDAHL
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2008
Decision Date
05/13/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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