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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 K041046
Device Name MAXIM ACCEL (VANGUARD) PS+ BEARINGS
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Applicant Contact TRACY J BICKEL
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Correspondent Contact TRACY J BICKEL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/22/2004
Decision Date 05/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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