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FDA 510(k) Application Details - K091493
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K091493
Device Name
Plate, Fixation, Bone
Applicant
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT
AMSTEL 320-1
AMSTERDAM 1017AP NL
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Contact
ANGELIKA SCHERP
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/2009
Decision Date
02/05/2010
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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