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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 K833921
Device Name AGC TOTAL KNEE PROSTHESIS
Applicant
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/14/1983
Decision Date 01/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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