GC GAM-100


Device Classification Name

cement, dental

510(k) Number K073283
Device Name GC GAM-100
Applicant
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Applicant Contact mark heiss
Correspondent
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Correspodent Contact mark heiss
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 11/21/2007
Decision Date 02/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No