INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K080136
Device Name INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
Applicant
STERITEC PRODUCTS, INC.
599 topeka way, suite 400
castle rock, 
CO 
80109

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

Correspodent Contact linda nelson
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 01/22/2008
Decision Date 08/15/2008
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