Device Classification Name |
sterilizer, steam
|
510(k) Number |
K092490 |
Device Name |
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 |
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 | 880.6880
|
Classification Product Code |
|
Date Received | 08/13/2009 |
Decision Date | 11/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|