FDA 510(k) Application Details - K031761

Device Classification Name Plate, Bone

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510(K) Number K031761
Device Name Plate, Bone
Applicant SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301 US
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Contact Lisa Boyle
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 06/06/2003
Decision Date 09/03/2003
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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