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FDA 510(k) Application Details - K040022
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K040022
Device Name
Plate, Fixation, Bone
Applicant
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact
WADE T RUTKOSKIE
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
01/07/2004
Decision Date
03/12/2004
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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