Device Classification Name |
Sterilizer, Chemical
|
510(k) Number |
K182568 |
Device Name |
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
Bill Brodbeck |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
Bill Brodbeck |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 09/18/2018 |
Decision Date | 01/03/2019 |
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
|
|
|