Device Classification Name |
sterilizer, chemical
|
510(k) Number |
K160433 |
Device Name |
V-PRO® 1 Plus and V-PRO® maX Low Temperature |
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 | 02/16/2016 |
Decision Date | 07/06/2016 |
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
|
|
|