Device Classification Name |
Sterilizer, Chemical
|
510(k) Number |
K062297 |
Device Name |
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
PATRICK J MCCULLAGH |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
PATRICK J MCCULLAGH |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 08/07/2006 |
Decision Date | 10/04/2007 |
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
|
|
|