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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, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K110404
Device Name EAUM TOTAL KNEE SYSTEM
Applicant
CORENTEC CO., LTD
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
CORENTEC CO., LTD
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/14/2011
Decision Date 02/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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