Device Classification Name |
Sterilant, Medical Devices
|
510(k) Number |
K192929 |
Device Name |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
Jennifer Nalepka |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
Jennifer Nalepka |
Regulation Number | 880.6885
|
Classification Product Code |
|
Date Received | 10/17/2019 |
Decision Date | 12/10/2019 |
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
|
|
|