FDA 510(k) Application Details - K130874

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K130874
Device Name Neurological Stereotaxic Instrument
Applicant STRYKER CORPORATE
BOETZINGER STR. 41
FREIBURG, BADEN-WUERTTEMBERG 79111 DE
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Contact LILIAN ECKERT
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 03/29/2013
Decision Date 09/27/2013
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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