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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, Antibiotic
510(k) Number K150850
FOIA Releasable 510(k) K150850
Device Name Refobacin Bone Cement R
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact CARMEN ALBANY
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact CARMEN ALBANY
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Code
LOD  
Date Received03/31/2015
Decision Date 07/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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