ISO FUNCTIONAL


Device Classification Name

material, impression

510(k) Number K022430
Device Name ISO FUNCTIONAL
Original Applicant
GC AMERICA, INC.
3737 west 127th st.
alsip, 
IL 
60803

Original Contact terry l joritz
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 07/25/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No