Device Classification Name |
Sterilant, Medical Devices
|
510(k) Number |
K090036 |
Device Name |
SYSTEM 1.5 STERILE PROCESSING SYSTEM |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
PETER BURKE |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
PETER BURKE |
Regulation Number | 880.6885
|
Classification Product Code |
|
Date Received | 01/06/2009 |
Decision Date | 04/05/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|