STERRAD CHEMIAL INDICATOR STRIP MODEL 14100


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K111518
Device Name STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Applicant Contact nancy chu
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Correspodent Contact nancy chu
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 06/02/2011
Decision Date 10/03/2012
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