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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K060445
Device Name NORIAN CRS BONE CEMENT
Applicant
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact ANGELA SILVESTRI
Correspondent
Synthes (Usa)
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact ANGELA SILVESTRI
Regulation Number882.5300
Classification Product Code
GXP  
Date Received02/21/2006
Decision Date 04/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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