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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 K882869
Device Name TOWNLEY COX COMB ACETABULAR COMPONENT
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 Received07/11/1988
Decision Date 10/14/1988
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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