FDA 510(k) Application Details - K061725

Device Classification Name Motor, Drill, Pneumatic

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510(K) Number K061725
Device Name Motor, Drill, Pneumatic
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact VALERIE FRANCK
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Regulation Number 882.4370

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Classification Product Code HBB
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Date Received 06/19/2006
Decision Date 10/26/2006
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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