STERRAD SEALSURE CHEMICAL INDICATOR TAPE


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K022441
Device Name STERRAD SEALSURE CHEMICAL INDICATOR TAPE
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Original Contact natalie bennington
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 07/25/2002
Decision Date 10/08/2002
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