FDA 510(k) Application Details - K110198

Device Classification Name	Bone Grafting Material, For Dental Bone Repair   More FDA Info for this Device
510(K) Number	K110198
Device Name	Bone Grafting Material, For Dental Bone Repair
Applicant	BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 GRAYSLAKE, IL 60030 US Other 510(k) Applications for this Company
Contact	MICHELE VOVOLKA Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2011
Decision Date	12/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review