FDA 510(k) Application Details - K113251

Device Classification Name Plate, Bone

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510(K) Number K113251
Device Name Plate, Bone
Applicant SYNTHES INC
1302 GOSHEN PARKWAY
WEST CHESTER, PA 19380 US
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Contact ALAN HALEY
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 11/03/2011
Decision Date 12/21/2011
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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