510(k) K190103

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System by STERIS Corporation — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2019
Date Received
January 22, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type