FDA 510(k) Application Details - K061881

Device Classification Name Plate, Bone

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510(K) Number K061881
Device Name Plate, Bone
Applicant TAKIRON CO., LTD
405 NAGANO, YASUTOMI-CHO
HIMEJI 671-2421 JP
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Contact KUNIHIRO HATA
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 07/03/2006
Decision Date 03/14/2007
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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