TRICOS T RESORBABLE BONE SUBSTITUTE


Device Classification Name

bone grafting material, synthetic

510(k) Number K073571
Device Name TRICOS T RESORBABLE BONE SUBSTITUTE
Applicant
BAXTER HEALTHCARE CORPORATION
1620 waukegan road
mpgr-al
mcgaw park, 
IL 
60085

Applicant Contact barbara k barbeau
Correspondent
BAXTER HEALTHCARE CORPORATION
1620 waukegan road
mpgr-al
mcgaw park, 
IL 
60085

Correspodent Contact barbara k barbeau
Regulation Number 872.3930
Classification Product Code
LYC  
Subsequent Product Code
NUN  
Date Received 12/20/2007
Decision Date 04/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

Yes