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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 K993889
Device Name EXETER CERAMIC FEMORAL HEADS
Applicant
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact NANCY J RIEDER
Correspondent
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact NANCY J RIEDER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/16/1999
Decision Date 02/11/2000
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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