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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K042896
Device Name SMITH & NEPHEW HYBRID KNEE FEMORAL
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact KIM P KELLY
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact KIM P KELLY
Regulation Number888.3560
Classification Product Code
NPJ  
Date Received10/20/2004
Decision Date 01/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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