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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 K840150
Device Name TOTAL HIP FEMORAL COMPONENT
Applicant
Advanced Biosearch Assn.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Advanced Biosearch Assn.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
JDG  
Date Received01/13/1984
Decision Date 02/27/1984
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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