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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 the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-08-06 under 510(k) 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. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K200858.

When did Mini Sterilizable Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for Mini Sterilizable Tray?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini Sterilizable Tray?

The FDA product code for Mini Sterilizable Tray is KCT.

Other records listing Implant Direct Sybron Manufacturing, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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