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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 K960302
Device Name CONSENSUS ACETABULAR SHELL, ALL UHMWPE
Applicant
U.S. Medical Products, Inc.
12201 Technology Blvd., #100
Austin,  TX  78727
Applicant Contact WILLIAM N THOMPSON
Correspondent
U.S. Medical Products, Inc.
12201 Technology Blvd., #100
Austin,  TX  78727
Correspondent Contact WILLIAM N THOMPSON
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/22/1996
Decision Date 04/01/1996
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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