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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, Uncemented, Metal/Polymer, Porous
510(k) Number K070756
Device Name SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact NICHOLAS TABRIZI
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact NICHOLAS TABRIZI
Regulation Number888.3358
Classification Product Code
MBL  
Date Received03/20/2007
Decision Date 06/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
Recalls CDRH Recalls
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