STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR


Device Classification Name

indicator, biological sterilization process

510(k) Number K111375
Device Name STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
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
FRC  
Date Received 05/16/2011
Decision Date 09/14/2012
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