TSO3 OZONE CHEMICAL INDICATOR


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K021161
Device Name TSO3 OZONE CHEMICAL INDICATOR
Original Applicant
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
33 black watch trail
fairport, 
NY 
14450

Original Contact charles o hancock
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 04/11/2002
Decision Date 08/27/2003
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