FDA 510(k) Application Details - K954690

Device Classification Name Drill, Bone, Powered

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510(K) Number K954690
Device Name Drill, Bone, Powered
Applicant STRYKER CORP.
2725 FAIRFIELD RD.
P.O. BOX 4085
KALAMAZOO, MI 49003-4085 US
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Contact TAMMY LOUNDS
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Regulation Number 872.4120

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Classification Product Code DZI
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Date Received 10/11/1995
Decision Date 08/20/1996
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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