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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K872856
Device Name BIOPRO 32MM BALL
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact SERAFIN, JR.MD
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact SERAFIN, JR.MD
Regulation Number888.3350
Classification Product Code
JDI  
Date Received07/21/1987
Decision Date 08/17/1987
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
Recalls CDRH Recalls
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