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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K002325
Device Name WUJIN #3 TIBIAL NAIL
Applicant
Biologically Oriented Prostheses
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact ANGENA PAREKH
Correspondent
Biologically Oriented Prostheses
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact ANGENA PAREKH
Regulation Number888.3030
Classification Product Code
JDS  
Date Received08/01/2000
Decision Date 10/30/2000
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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