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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 K912245
Device Name AGC REVISION KNEE PROTHESIS
Applicant
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA M SANDBORN
Correspondent
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA M SANDBORN
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/21/1991
Decision Date 08/19/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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