FDA 510(k) Application Details - K162929

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K162929
Device Name Neurological Stereotaxic Instrument
Applicant Stryker Corporation
Botzinger Strasse 41
Freiburg Baden-Wurttemberg D-79111 DE
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Contact Brittney M. Larsen
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 10/19/2016
Decision Date 02/22/2017
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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