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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 K921182
Device Name ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA BERES
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA BERES
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
HRY  
Date Received03/10/1992
Decision Date 07/23/1993
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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