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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 K060525
Device Name VANGUARD REMOVABLE MOLDED POLY TIBIA
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact TRACY BICKEL JOHNSON
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact TRACY BICKEL JOHNSON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/27/2006
Decision Date 05/25/2006
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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