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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 K030902
Device Name PALACOS R
Applicant
Heraeus Kulzer GmbH & Co. KG
Gruner Weg 11
Hanau,  DE D-63450
Applicant Contact K.D. KUHN
Correspondent
Heraeus Kulzer GmbH & Co. KG
Gruner Weg 11
Hanau,  DE D-63450
Correspondent Contact K.D. KUHN
Regulation Number888.3027
Classification Product Code
LOD  
Date Received03/24/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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