FDA 510(k)

CIDEX OPA CONCENTRATE

K-Number: K032959 · 2005-04-04

ApplicantAdvanced Sterilization Products

Decision Date2005-04-04

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CIDEX OPA CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2005-04-04 under 510(k) number K032959. 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 CIDEX OPA CONCENTRATE?

CIDEX OPA CONCENTRATE is a medical device that received FDA 510(k) clearance on 2005-04-04. The listed applicant is Advanced Sterilization Products. The 510(k) number is K032959.

When did CIDEX OPA CONCENTRATE receive FDA 510(k) clearance?

CIDEX OPA CONCENTRATE received FDA 510(k) clearance on 2005-04-04, under 510(k) number K032959.

Who is the listed applicant for CIDEX OPA CONCENTRATE?

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

What is the FDA product code for CIDEX OPA CONCENTRATE?

The FDA product code for CIDEX OPA CONCENTRATE 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.