Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

Wrap, Sterilization

Steris

The following data is part of a premarket notification filed by Steris with the FDA for Vis-u-all Low Temperature Sterilization Pouches/tubing, Pro-lite Sterilization Trays.

Pre-market Notification Details

Device IDK222440
510k NumberK222440
Device Name:Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
ClassificationWrap, Sterilization
Applicant Steris 5960 Heisey Road Mentor,  OH  44060
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
Steris 5960 Heisey Road Mentor,  OH  44060
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-12
Decision Date2022-09-09

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