EMU-GRAPH EMULATOR, MODEL CI 131


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K072408
Device Name EMU-GRAPH EMULATOR, MODEL CI 131
Applicant
STERITEC PRODUCTS MFG. CO., INC.
599 topeka way
suite 400
castle rock, 
CO 
80109

Applicant Contact linda nelson
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
599 topeka way
suite 400
castle rock, 
CO 
80109

Correspodent Contact linda nelson
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 08/27/2007
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No