FDA 510(k)

0.55% ORTH-PHTHALALDEHYDE SOLUTION

K-Number: K030004 · 2003-02-27

ApplicantAdvanced Sterilization Products

Decision Date2003-02-27

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

0.55% ORTH-PHTHALALDEHYDE 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 2003-02-27 under 510(k) number K030004. 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 0.55% ORTH-PHTHALALDEHYDE SOLUTION?

0.55% ORTH-PHTHALALDEHYDE SOLUTION is a medical device that received FDA 510(k) clearance on 2003-02-27. The listed applicant is Advanced Sterilization Products. The 510(k) number is K030004.

When did 0.55% ORTH-PHTHALALDEHYDE SOLUTION receive FDA 510(k) clearance?

0.55% ORTH-PHTHALALDEHYDE SOLUTION received FDA 510(k) clearance on 2003-02-27, under 510(k) number K030004.

Who is the listed applicant for 0.55% ORTH-PHTHALALDEHYDE 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 0.55% ORTH-PHTHALALDEHYDE SOLUTION?

The FDA product code for 0.55% ORTH-PHTHALALDEHYDE 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.