VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack— 510(k) K162758

Clearance details

Applicant

STERIS Corporation

Product code

Code JOJ

Device class

Class 2

Regulation

21 CFR 880.2800

Advisory panel

General Hospital

Date received

2016-09-30

Decision date

2017-03-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mentor, OH, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162758.