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FDA 510(k) Application Details - K080109
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
More FDA Info for this Device
510(K) Number
K080109
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER, PA 19380 US
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Contact
JILL R SHERMAN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/15/2008
Decision Date
03/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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