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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
Applicant
BIOPRO, INC.
17 seventeenth st.
port huron,  MI  48060
Applicant Contact patrick pringle
Correspondent
BIOPRO, INC.
17 seventeenth st.
port huron,  MI  48060
Correspodent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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