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FDA 510(k) Application Details - K063832
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device
510(K) Number
K063832
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER, PA 19380 US
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Contact
JENNIFER PERKS
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
LXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2006
Decision Date
03/07/2007
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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