FDA 510(k)

ONE TRAY SEALED STERILIZATION CONTAINER

K-Number: K052567 · 2006-03-13

ApplicantSterile Containment Technology, LLC

Decision Date2006-03-13

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ONE TRAY SEALED STERILIZATION CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Containment Technology, LLC. It received FDA 510(k) clearance on 2006-03-13 under 510(k) number K052567. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE TRAY SEALED STERILIZATION CONTAINER?

ONE TRAY SEALED STERILIZATION CONTAINER is a medical device that received FDA 510(k) clearance on 2006-03-13. The listed applicant is Sterile Containment Technology, LLC. The 510(k) number is K052567.

When did ONE TRAY SEALED STERILIZATION CONTAINER receive FDA 510(k) clearance?

ONE TRAY SEALED STERILIZATION CONTAINER received FDA 510(k) clearance on 2006-03-13, under 510(k) number K052567.

Who is the listed applicant for ONE TRAY SEALED STERILIZATION CONTAINER?

The FDA 510(k) record lists Sterile Containment Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE TRAY SEALED STERILIZATION CONTAINER?

The FDA product code for ONE TRAY SEALED STERILIZATION CONTAINER is KCT.

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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.