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FDA 510(k) Application Details - K012655
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K012655
Device Name
Plate, Fixation, Bone
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON, OR 97005 US
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Contact
SHARI JEFFERS
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
08/13/2001
Decision Date
11/07/2001
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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