SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM— 510(k) K101409

Clearance details

Applicant

STERIS Corporation

Product code

Code MED

Device class

Class 2

Regulation

21 CFR 880.6885

Advisory panel

General Hospital

Date received

2010-05-19

Decision date

2010-08-02

Decision

Substantially Equivalent

Clearance type

Special

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 K101409.