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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 K051093
FOIA Releasable 510(k) K051093
Device Name OSTEOPORE PCL SCAFFOLD
Applicant
Osteopore, Inc.
958 Kristin Ridge Way
Milpitas,  CA  95035
Applicant Contact ALEXANDER YEO
Correspondent
Osteopore, Inc.
958 Kristin Ridge Way
Milpitas,  CA  95035
Correspondent Contact ALEXANDER YEO
Regulation Number882.5300
Classification Product Code
GXP  
Date Received04/28/2005
Decision Date 03/17/2006
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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