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FDA 510(k) Application Details - K061783
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K061783
Device Name
Nail, Fixation, Bone
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact
JOHN REABE
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2006
Decision Date
08/10/2006
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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