V-PRO MaX 2 Low Temperature Sterilization System, V-PRO MaX Low Temperature Sterilization System

Sterilizer, Chemical

STERIS

The following data is part of a premarket notification filed by Steris with the FDA for V-pro Max 2 Low Temperature Sterilization System, V-pro Max Low Temperature Sterilization System.

Pre-market Notification Details

Device IDK222093
510k NumberK222093
Device Name:V-PRO MaX 2 Low Temperature Sterilization System, V-PRO MaX Low Temperature Sterilization System
ClassificationSterilizer, Chemical
Applicant STERIS 5960 Heisley Rd Mentor,  OH  44024
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
STERIS 5960 Heisley Rd Mentor,  OH  44060
Product CodeMLR  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-15
Decision Date2022-09-09

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