THE RELIANCE ENDOSCOPE PROCESSING SYSTEM— 510(k) K040049

Clearance details

Applicant

STERIS Corporation

Product code

Code NZA

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2004-01-12

Decision date

2004-12-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mentor, OH, US

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• Z-2263-2013 — Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.Class II·Terminated·Steris Corporation·20130829

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040049.