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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 K852765
Device Name HA-2000 HYDROXYLAPATITE
Applicant
Orthomatrix, Inc.
6968 Sierra Ct.
Dublin,  CA  94568
Applicant Contact THOMAS E CANE
Correspondent
Orthomatrix, Inc.
6968 Sierra Ct.
Dublin,  CA  94568
Correspondent Contact THOMAS E CANE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/28/1985
Decision Date 09/23/1985
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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