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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 K111105
Device Name CURASAN OSSEOLIVE DENTAL
Original Applicant
CURASAN AG
piazza albania 10
rome,  IT 00153
Original Contact roger gray
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/20/2011
Decision Date 12/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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