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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessory, barium sulfate, methyl methacrylate for cranioplasty
510(k) Number K032388
Device Name BONE CEMENT RADIO-OPACIFIER
Applicant
Cardinal Health
1500 WAUKEGAN RD.
MCGAW PARK,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
Cardinal Health
1500 WAUKEGAN RD.
MCGAW PARK,  IL  60085
Correspondent Contact SHARON NICHOLS
Regulation Number882.5300
Classification Product Code
MYU  
Date Received08/04/2003
Decision Date 10/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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