Device Classification Name |
sterilizer, chemical
|
510(k) Number |
K102330 |
Device Name |
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
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 | 880.6860
|
Classification Product Code |
|
Date Received | 08/17/2010 |
Decision Date | 08/12/2011 |
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
|
|
|