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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 K871462
Device Name PROSTHETIC - FEMORAL HIP COMPONENT
Applicant
Louis A. Serafin, Jr., M.D.
3315 Berry Dr.
Port Huron,  MI  48060
Correspondent
Louis A. Serafin, Jr., M.D.
3315 Berry Dr.
Port Huron,  MI  48060
Regulation Number888.3350
Classification Product Code
JDI  
Date Received04/14/1987
Decision Date 06/04/1987
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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