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FDA 510(k)

RESTORE MODULAR STERILIZATION TRAY SYSTEM

K-Number: K131455 · 2013-08-30

ApplicantRestore Medical Solutions, Inc.
Decision Date2013-08-30
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RESTORE MODULAR STERILIZATION TRAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Restore Medical Solutions, Inc.. It received FDA 510(k) clearance on 2013-08-30 under 510(k) number K131455. 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 RESTORE MODULAR STERILIZATION TRAY SYSTEM?

RESTORE MODULAR STERILIZATION TRAY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is Restore Medical Solutions, Inc.. The 510(k) number is K131455.

When did RESTORE MODULAR STERILIZATION TRAY SYSTEM receive FDA 510(k) clearance?

RESTORE MODULAR STERILIZATION TRAY SYSTEM received FDA 510(k) clearance on 2013-08-30, under 510(k) number K131455.

Who is the listed applicant for RESTORE MODULAR STERILIZATION TRAY SYSTEM?

The FDA 510(k) record lists Restore Medical Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESTORE MODULAR STERILIZATION TRAY SYSTEM?

The FDA product code for RESTORE MODULAR STERILIZATION TRAY SYSTEM is KCT.

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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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.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.

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.

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