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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 Component, Cemented, Metal
510(k) Number K874868
Device Name OPTI-FIX COLLARED FEMORAL COMPONENTS
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number888.3360
Classification Product Code
JDG  
Date Received11/27/1987
Decision Date 01/26/1988
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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