AMSCO WARMING CABINET

Warmer, Thermal, Infusion Fluid

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Warming Cabinet.

Pre-market Notification Details

Device IDK092823
510k NumberK092823
Device Name:AMSCO WARMING CABINET
ClassificationWarmer, Thermal, Infusion Fluid
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactRobert F Sullivan
CorrespondentRobert F Sullivan
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeLGZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-14
Decision Date2009-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00724995153939 K092823 000

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