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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K051532
Device Name COBALT G HV BONE CEMENT
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Applicant Contact LONNIE WITHAM
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact LONNIE WITHAM
Regulation Number888.3027
Classification Product Code
LOD  
Date Received06/09/2005
Decision Date 08/03/2005
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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