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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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TAMMY LOUNDS
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Regulation Number
872.4120
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Classification Product Code
DZI
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More FDA Info for this Product Code
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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