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FDA 510(k)

Standard Sterilizable Tray

K-Number: K202524 · 2021-01-28

Decision Date2021-01-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Standard Sterilizable Tray is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2021-01-28 under approval number K202524. 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 Standard Sterilizable Tray?

Standard Sterilizable Tray is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K202524.

When was Standard Sterilizable Tray approved by the FDA?

Standard Sterilizable Tray received FDA 510(k) clearance on 2021-01-28, under approval number K202524.

What company makes Standard Sterilizable Tray?

Standard Sterilizable Tray is manufactured by Implant Direct Sybron Manufacturing, LLC.

What is the FDA product code for Standard Sterilizable Tray?

The FDA product code for Standard Sterilizable Tray is KCT.

Other Devices by Implant Direct Sybron Manufacturing, LLC

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Related Devices (Code: KCT)

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.