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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 K936127
Device Name HOWMEDICA PREMIUM FEMORAL COMPONENT
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Applicant Contact ROBERT E SMITH
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Correspondent Contact ROBERT E SMITH
Regulation Number888.3350
Classification Product Code
JDI  
Date Received12/23/1993
Decision Date 10/26/1994
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
Recalls CDRH Recalls
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