FDA 510(k) Application Details - K010969

Device Classification Name Generator, Lesion, Radiofrequency

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510(K) Number K010969
Device Name Generator, Lesion, Radiofrequency
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact ROBIN L ROWE
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Regulation Number 882.4400

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Classification Product Code GXD
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Date Received 04/02/2001
Decision Date 04/20/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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