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FDA 510(k) Application Details - K200043
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K200043
Device Name
Plate, Fixation, Bone
Applicant
Field Orthopaedics Pty Ltd
375 Wickham Terrace
Spring Hill 4000 AU
Other 510(k) Applications for this Company
Contact
Kieran Leacy
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
01/08/2020
Decision Date
03/23/2020
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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