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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, for dental bone repair
510(k) Number K110198
Device Name BLUE SKY BIO TCP
Original Applicant
BLUE SKY BIO, LLC
888 e belvidere rd.
suite 212
grayslake,  IL  60030
Original Contact michele vovolka
Regulation Number872.3930
Classification Product Code
LPK  
Date Received01/24/2011
Decision Date 12/22/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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