BLUE SKY BIO TCP


Device Classification Name

bone grafting material, for dental bone repair

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

Correspodent Contact michele vovolka
Regulation Number 872.3930
Classification Product Code
LPK  
Date Received 01/24/2011
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