Device Classification Name |
sterilizer, chemical
|
510(k) Number |
K112813 |
Device Name |
AMSCO V-PRO |
Applicant |
STERIS CORP. |
5960 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
ROBERT SULLIVAN |
Correspondent |
STERIS CORP. |
5960 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
ROBERT SULLIVAN |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 09/27/2011 |
Decision Date | 12/01/2011 |
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
|
|
|