Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K103331 |
Device Name |
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
ROBERT F SULLIVAN |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
ROBERT F SULLIVAN |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 11/12/2010 |
Decision Date | 09/01/2011 |
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
|
|
|