FDA 510(k)

CIDEX OPA SOLUTION

K-Number: K991487 · 1999-10-08

ApplicantAdvanced Sterilization Products

Decision Date1999-10-08

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CIDEX OPA SOLUTION 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 1999-10-08 under 510(k) number K991487. 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 SOLUTION?

CIDEX OPA SOLUTION is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Advanced Sterilization Products. The 510(k) number is K991487.

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

CIDEX OPA SOLUTION received FDA 510(k) clearance on 1999-10-08, under 510(k) number K991487.

Who is the listed applicant for CIDEX OPA SOLUTION?

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 SOLUTION?

The FDA product code for CIDEX OPA SOLUTION 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.