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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 K964537
Device Name BONESOURCE HYDROXYAPATITE CEMENT (HAC)
Applicant
Osteogenics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Applicant Contact MARY BIGGERS
Correspondent
Osteogenics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Correspondent Contact MARY BIGGERS
Regulation Number882.5300
Classification Product Code
GXP  
Date Received11/12/1996
Decision Date 01/24/1997
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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