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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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NICOLE PETTY
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Regulation Number
882.4725
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Classification Product Code
GXI
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More FDA Info for this Product Code
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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