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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K002320
Device Name ACCOLADE C FEMORAL COMPONENT
Applicant
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Applicant Contact NANCY J RIEDER
Correspondent
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Correspondent Contact NANCY J RIEDER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/31/2000
Decision Date 09/14/2000
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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