RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

Washer, Cleaner, Automated, Endoscope

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Ras 12 Rack, Ras 12 Long Rack, Ras Cycle Of The Amsco 7052hp/7053hp Single Chamber Washer/disinfector.

Pre-market Notification Details

Device IDK200577
510k NumberK200577
Device Name:RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
ClassificationWasher, Cleaner, Automated, Endoscope
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactJennifer Nalepka
CorrespondentJennifer Nalepka
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeNVE  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2020-04-03

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