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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 K000633
Device Name SYNTHETIC GLASS BONE GRAFT MATERIAL
Applicant
BLUE SKY BIO
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact RITA GIEBEL
Correspondent
BLUE SKY BIO
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact RITA GIEBEL
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/25/2000
Decision Date 05/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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