FDA 510(k) Application Details - K032406

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K032406
Device Name Probe, Radiofrequency Lesion
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact NICOLE PETTY
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 08/04/2003
Decision Date 04/01/2004
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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