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FDA 510(k) Application Details - K142568
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K142568
Device Name
Plate, Bone
Applicant
Stryker
750 Trade Centre Way - Suite 200
Portage, MI 49009 US
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Contact
Julie Schoell
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Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
09/12/2014
Decision Date
05/05/2015
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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