Amsco Evolution Medium Steam Sterilizer (Models HC-900 And HC-1200),Evolution Automated Loading And Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 And HC-1500),Evolution Automated Loading And Unloading System (ALUS); A

Sterilizer, Steam

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Evolution Medium Steam Sterilizer (models Hc-900 And Hc-1200),evolution Automated Loading And Unloading System (alus); Amsco Evolutionmedium Steam Sterilizer (models Hc-600 And Hc-1500),evolution Automated Loading And Unloading System (alus); A.

Pre-market Notification Details

Device IDK203061
510k NumberK203061
Device Name:Amsco Evolution Medium Steam Sterilizer (Models HC-900 And HC-1200),Evolution Automated Loading And Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 And HC-1500),Evolution Automated Loading And Unloading System (ALUS); A
ClassificationSterilizer, Steam
Applicant STERIS Corporation 5960 Heisley Rd Mentor,  OH  44060
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
STERIS Corporation 5960 Heisley Rd Mentor,  OH  44060
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-08
Decision Date2020-11-06

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