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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K882098
Device Name DENTORIDGE(TM) HYDROXYYLAPATITE
Applicant
Norian Corp.
1030 Hamilton Court
Menlo Park,  CA  94025
Applicant Contact WINSTON A ANDREWS
Correspondent
Norian Corp.
1030 Hamilton Court
Menlo Park,  CA  94025
Correspondent Contact WINSTON A ANDREWS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/19/1988
Decision Date 06/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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