TSO3 OZONE STERILIZATION WRAP


Device Classification Name

wrap, sterilization

510(k) Number K080198
Device Name TSO3 OZONE STERILIZATION WRAP
Applicant
TSO3 INC.
33 black watch trail
fairport, 
NY 
14450

Applicant Contact charles o hancock
Correspondent
TSO3 INC.
33 black watch trail
fairport, 
NY 
14450

Correspodent Contact charles o hancock
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 01/25/2008
Decision Date 05/30/2008
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