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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 K984623
Device Name MAXIM REMOVABLE MOLDED POLY TIBIA
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact FRED MCCLURE
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact FRED MCCLURE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/30/1998
Decision Date 03/05/1999
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
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