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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 K963709
Device Name CEMENT-ON FEMORAL STEM
Applicant
Biomet, Inc.
Airport Industrial Park
Warsaw,  IN  46581
Applicant Contact KARA L SCHWARTZ
Correspondent
Biomet, Inc.
Airport Industrial Park
Warsaw,  IN  46581
Correspondent Contact KARA L SCHWARTZ
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/16/1996
Decision Date 12/04/1996
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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