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FDA 510(k) Application Details - K063790
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K063790
Device Name
Plate, Bone
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER, PA 19380 US
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Contact
DEBORAH L JACKSON
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2006
Decision Date
04/16/2007
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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