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FDA 510(k)

Mini Sterilizable Tray

K-Number: K200858 · 2020-08-06

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2020-08-06
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Mini Sterilizable Tray is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-08-06 under approval number K200858. 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 Mini Sterilizable Tray?

Mini Sterilizable Tray is a medical device that received FDA 510(k) clearance on 2020-08-06. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K200858.

When was Mini Sterilizable Tray approved by the FDA?

Mini Sterilizable Tray received FDA 510(k) clearance on 2020-08-06, under approval number K200858.

What company makes Mini Sterilizable Tray?

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

What is the FDA product code for Mini Sterilizable Tray?

The FDA product code for Mini Sterilizable Tray is KCT.

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Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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