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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 K080308
Device Name BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
Applicant
BIOSCAFFOLD INTERNATIONAL PTE LTD
PIAZZA ALBANIA, 10
ROME,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
BIOSCAFFOLD INTERNATIONAL PTE LTD
PIAZZA ALBANIA, 10
ROME,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number872.3930
Classification Product Code
LYC  
Subsequent Product Code
NPK  
Date Received02/05/2008
Decision Date 04/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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