FDA 510(k) Application Details - K943540

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

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510(K) Number K943540
Device Name Driver, Wire, And Bone Drill, Manual
Applicant STRYKER CORP.
4100 E MILHAM AVE.
PORTAGE, MI US
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Contact TAMMY LOUNDS
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Regulation Number 872.4120

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Classification Product Code DZJ
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Date Received 07/22/1994
Decision Date 11/30/1994
Decision SE - Substantially Equivalent
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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