TBM SPONGE


Device Classification Name

bone grafting material, synthetic

510(k) Number K960267
Device Name TBM SPONGE
Applicant
BIOCOLL LABORATORIES, INC.
1247 florida ave.
palm harbor, 
FL 
34683

Applicant Contact ed ranson
Correspondent
BIOCOLL LABORATORIES, INC.
1247 florida ave.
palm harbor, 
FL 
34683

Correspodent Contact ed ranson
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 01/18/1996
Decision Date 11/05/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No