RAS 12 Rack, RAS 12 Long Rack; RAS Cycle Of 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 Amsco 7052hp/7053hp Single Chamber Washer/disinfector.

Pre-market Notification Details

Device IDK190081
510k NumberK190081
Device Name:RAS 12 Rack, RAS 12 Long Rack; RAS Cycle Of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
ClassificationWasher, Cleaner, Automated, Endoscope
Applicant STERIS Corporation 5960 Heisley Rd Mentor,  OH  44060
ContactMarcia L Benedict
CorrespondentMarcia L Benedict
STERIS Corporation 5960 Heisley Rd Mentor,  OH  44060
Product CodeNVE  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-16
Decision Date2019-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00724995176730 K190081 000
00724995176723 K190081 000

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