STERRAD(R) 100NX STERILIZER DUO CYCLE


Device Classification Name

sterilizer, chemical

510(k) Number K111377
Device Name STERRAD(R) 100NX STERILIZER DUO CYCLE
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 880.6860
Classification Product Code
MLR  
Date Received 05/16/2011
Decision Date 09/13/2012
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

Recalls CDRH Recalls