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FDA 510(k) Application Details - K972324
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K972324
Device Name
Neurological Stereotaxic Instrument
Applicant
ELEKTA INSTRUMENT AB
18140 SMOKESIGNAL DR.
SAN DIEGO, CA 92127 US
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Contact
CAROL PATTERSON
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
06/23/1997
Decision Date
03/02/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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