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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K011460
Device Name WUJIN #3 TIBIAL BONE PLATE
Original Applicant
BIOPRO, INC.
17 seventeenth st.
port huron,  MI  48060
Original Contact patrick pringle
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/11/2001
Decision Date 08/07/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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