Device Classification Name |
sterilizer, ethylene-oxide gas
|
510(k) Number |
K090636 |
Device Name |
TSO3 OZONE STERILIZER, MODEL 125L |
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
|
|
Correspondent Contact |
CHARLES O HANCOCK |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 03/10/2009 |
Decision Date | 12/02/2009 |
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
|
|
|