FDA 510(k) Application Details - K040369

Device Classification Name Driver, Wire, And Bone Drill, Manual

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510(K) Number K040369
Device Name Driver, Wire, And Bone Drill, Manual
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact JEAN W SHEPPARD
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Regulation Number 872.4120

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Classification Product Code DZJ
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Date Received 02/13/2004
Decision Date 04/01/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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