RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector— 510(k) K203199

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K203199 for RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector, Substantially Equivalent on 2020-12-01. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant
STERIS Corporation
Product code
Code NVE
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mentor, OH, US
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