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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 K051496
Device Name COBALT BONE CEMENT
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Applicant Contact LONNIE WITHAM
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Correspondent Contact LONNIE WITHAM
Regulation Number888.3027
Classification Product Code
LOD  
Date Received06/06/2005
Decision Date 08/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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