FDA 510(k)

RESERT XL HLD HIGH LEVEL DISINFECTANT

K-Number: K080420 · 2008-09-02

Decision Date2008-09-02

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

RESERT XL HLD HIGH LEVEL DISINFECTANT is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2008-09-02 under 510(k) number K080420. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESERT XL HLD HIGH LEVEL DISINFECTANT?

RESERT XL HLD HIGH LEVEL DISINFECTANT is a medical device that received FDA 510(k) clearance on 2008-09-02. The listed applicant is STERIS Corporation. The 510(k) number is K080420.

When did RESERT XL HLD HIGH LEVEL DISINFECTANT receive FDA 510(k) clearance?

RESERT XL HLD HIGH LEVEL DISINFECTANT received FDA 510(k) clearance on 2008-09-02, under 510(k) number K080420.

Who is the listed applicant for RESERT XL HLD HIGH LEVEL DISINFECTANT?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESERT XL HLD HIGH LEVEL DISINFECTANT?

The FDA product code for RESERT XL HLD HIGH LEVEL DISINFECTANT is MED.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.