AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

Sterilizer, Chemical

STERIS Corporation

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

Pre-market Notification Details

Device IDK112760
510k NumberK112760
Device Name:AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
ClassificationSterilizer, Chemical
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactRobert Sullivan
CorrespondentRobert Sullivan
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeMLR  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-22
Decision Date2011-11-22
Summary:summary

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