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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K043518
Device Name RADIOPAQUE BONE CEMENT
Applicant
Cardinalhealth
1430 Waukegan Rd.
Bldg. Kb
Mcgaw Park,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
Cardinalhealth
1430 Waukegan Rd.
Bldg. Kb
Mcgaw Park,  IL  60085
Correspondent Contact SHARON NICHOLS
Regulation Number888.3027
Classification Product Code
NDN  
Date Received12/20/2004
Decision Date 05/11/2005
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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