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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, Hemi-, Femoral, Metal Ball
510(k) Number K896580
Device Name UNI-POLAR HEAD
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number888.3360
Classification Product Code
LZY  
Date Received11/17/1989
Decision Date 02/15/1990
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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