Device Classification Name |
sterilant, medical devices
|
510(k) Number |
K101409 |
Device Name |
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
ROBERT SULLIVAN |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
ROBERT SULLIVAN |
Regulation Number | 880.6885
|
Classification Product Code |
|
Date Received | 05/19/2010 |
Decision Date | 08/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|