FDA 510(k) Application Details - K021499

Device Classification Name Bone Cement

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510(K) Number K021499
Device Name Bone Cement
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact JANET G JOHNSON
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Regulation Number 888.3027

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Classification Product Code LOD
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Date Received 05/09/2002
Decision Date 07/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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