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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 K920430
Device Name MODULAR ACETABULAR CUP SYSTEM
Applicant
SMITH & NEPHEW RICHARDS, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
SMITH & NEPHEW RICHARDS, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3350
Classification Product Code
JDI  
Date Received02/03/1992
Decision Date 07/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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