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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, porous uncemented
510(k) Number K071160
Device Name REFLECTION, TANDEM UNIPOLAR
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact MEGAN BEVILL
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact MEGAN BEVILL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
FZP   JDI   KWL   KWY   LWJ  
MEH   NEU  
Date Received04/26/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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