FDA 510(k) Application Details - K102656

Device Classification Name Plate, Bone

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510(K) Number K102656
Device Name Plate, Bone
Applicant SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER, PA 19380 US
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Contact ALAN T HALEY
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 09/15/2010
Decision Date 12/20/2010
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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