Device Classification Name |
Sterilizer, Ethylene-Oxide Gas
|
510(k) Number |
K020875 |
Device Name |
TSO3 OZONE STERILIZER, MODEL 125L |
Applicant |
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC |
33 BLACK WATCH TRAIL |
FAIRPORT,
NY
14450
|
|
Applicant Contact |
CHARLES O HANCOCK |
Correspondent |
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC |
33 BLACK WATCH TRAIL |
FAIRPORT,
NY
14450
|
|
Correspondent Contact |
CHARLES O HANCOCK |
Regulation Number | 880.6860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/2002 |
Decision Date | 08/26/2003 |
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
|
|
|