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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Cleaner, Automated, Endoscope
510(k) Number K190081
Device Name RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Marcia L Benedict
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Marcia L Benedict
Regulation Number876.1500
Classification Product Code
NVE  
Date Received01/16/2019
Decision Date 08/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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