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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, Femoral, Resurfacing
510(k) Number K894604
Device Name BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
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 Number888.3400
Classification Product Code
KXA  
Date Received07/20/1989
Decision Date 11/17/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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