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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 K973789
Device Name NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
Applicant
Norian Corp.
10260 Bubb Rd.
Cupertino,  CA  95014
Applicant Contact SUSANNE T SMITH
Correspondent
Norian Corp.
10260 Bubb Rd.
Cupertino,  CA  95014
Correspondent Contact SUSANNE T SMITH
Regulation Number882.5300
Classification Product Code
GXP  
Date Received10/06/1997
Decision Date 05/18/1998
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
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