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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 K060630
Device Name REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact KATIE LOGEROT
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact KATIE LOGEROT
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LWJ   LZO   MBL   MEH  
Date Received03/09/2006
Decision Date 06/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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