FDA 510(k) Application Details - K033223

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K033223
Device Name Neurological Stereotaxic Instrument
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact KAREN CAIN
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 10/06/2003
Decision Date 02/18/2004
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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