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FDA 510(k) Application Details - K071135
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K071135
Device Name
Neurological Stereotaxic Instrument
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O BOX 988
WARSAW, IN 46581-0988 US
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Contact
NATALIE S HECK
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
04/23/2007
Decision Date
05/23/2007
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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