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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 K110198
Device Name BLUE SKY BIO TCP
Applicant
BLUE SKY BIO, LLC
888 E BELVIDERE RD.
SUITE 212
GRAYSLAKE,  IL  60030
Applicant Contact MICHELE VOVOLKA
Correspondent
BLUE SKY BIO, LLC
888 E BELVIDERE RD.
SUITE 212
GRAYSLAKE,  IL  60030
Correspondent Contact MICHELE VOVOLKA
Regulation Number872.3930
Classification Product Code
LYC  
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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