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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 K851566
Device Name HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact JAMES L BARBARITO
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact JAMES L BARBARITO
Regulation Number888.3360
Classification Product Code
JDG  
Date Received04/16/1985
Decision Date 07/30/1985
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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