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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, Hemi-, Femoral, Metal
510(k) Number K872535
Device Name BIOPRO FEMORAL HIP COMPONENT
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact SERAFIN, JR.
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact SERAFIN, JR.
Regulation Number888.3360
Classification Product Code
KWL  
Date Received06/26/1987
Decision Date 08/26/1987
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
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