FDA 510(k) Application Details - K071135

Device Classification Name Neurological Stereotaxic Instrument

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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
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Regulation Number 882.4560

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Classification Product Code HAW
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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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