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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 K972792
Device Name DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact FRANK MAAS
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact FRANK MAAS
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
KWY  
Date Received07/28/1997
Decision Date 10/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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