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FDA 510(k) Application Details - K061881
Device Classification Name
Plate, Bone
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
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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