FDA 510(k) Application Details - K021382

Device Classification Name Plate, Bone

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510(K) Number K021382
Device Name Plate, Bone
Applicant SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI, PA 19301 US
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Contact BONNIE J SMITH
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 05/02/2002
Decision Date 05/16/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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