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FDA 510(k) Application Details - K053348
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K053348
Device Name
Neurological Stereotaxic Instrument
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH, NJ 07430 US
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Contact
VIVIAN KELLY
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
12/02/2005
Decision Date
08/04/2006
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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