AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS 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 1 Low Temperature Sterilization System; Amsco V-pro 1 Plus Low Temperature Sterilization System.

Pre-market Notification Details

Device IDK102394
510k NumberK102394
Device Name:AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-23
Decision Date2011-08-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.