STERRAD 50 & STERRAD 100S STERILIZERS


Device Classification Name

sterilizer, ethylene-oxide gas

510(k) Number K023290
Device Name STERRAD 50 & STERRAD 100S STERILIZERS
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Original Contact natalie bennington
Regulation Number 880.6860
Classification Product Code
FLF  
Date Received 10/02/2002
Decision Date 04/03/2003
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