SYNTHETIC GLASS BONE GRAFT MATERIAL


information about

Device Classification Name

bone grafting material, synthetic

510(k) Number K000633
Device Name SYNTHETIC GLASS BONE GRAFT MATERIAL
Original Applicant
BLUE SKY BIO
3722 ave. sausalito
irvine, 
CA 
92606

Original Contact rita giebel
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 02/25/2000
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