INDISTRIP GREEN


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K110369
Device Name INDISTRIP GREEN
Applicant
INDILAB, INC.
10367 franklin ave.
franklin park, 
IL 
60131

Applicant Contact mark espenscheid
Correspondent
INDILAB, INC.
10367 franklin ave.
franklin park, 
IL 
60131

Correspodent Contact mark espenscheid
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 02/08/2011
Decision Date 05/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No