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FDA 510(k) Application Details - K023417
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K023417
Device Name
Staple, Fixation, Bone
Applicant
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER, MA 01810 US
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Contact
JASON BILOBRAM
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2002
Decision Date
11/07/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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