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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, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K030923
Device Name EPSILON DURASUL CONSTRAINED ACETABULAR LINER
Applicant
Centerpulse Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact ROBERT M WOLFARTH
Correspondent
Centerpulse Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact ROBERT M WOLFARTH
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received03/24/2003
Decision Date 10/03/2003
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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