FDA 510(k) Application Details - K093206

Device Classification Name Orthopedic Stereotaxic Instrument

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510(K) Number K093206
Device Name Orthopedic Stereotaxic Instrument
Applicant STRYKER CORP.
BOTZINGER STRABE 41
FREIBURG D-79111 DE
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Contact LILIAN ECKERT
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Regulation Number 882.4560

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Classification Product Code OLO
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Date Received 10/13/2009
Decision Date 08/04/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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