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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K010149
Device Name WUJIN #3 FEMORAL NAIL
Applicant
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact ANGENA PAREKH
Correspondent
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact ANGENA PAREKH
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/17/2001
Decision Date 04/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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