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FDA 510(k)

MTR550 (Tentative) Antimicrobial Silver Wound Gel

K-Number: K152519 · 2016-06-02

ApplicantMedical Technology Research, Inc.
Decision Date2016-06-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MTR550 (Tentative) Antimicrobial Silver Wound Gel is a medical device manufactured by Medical Technology Research, Inc.. It received FDA 510(k) clearance on 2016-06-02 under approval number K152519. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTR550 (Tentative) Antimicrobial Silver Wound Gel?

MTR550 (Tentative) Antimicrobial Silver Wound Gel is a medical device that received FDA 510(k) clearance on 2016-06-02. It is manufactured by Medical Technology Research, Inc.. The 510(k) number is K152519.

When was MTR550 (Tentative) Antimicrobial Silver Wound Gel approved by the FDA?

MTR550 (Tentative) Antimicrobial Silver Wound Gel received FDA 510(k) clearance on 2016-06-02, under approval number K152519.

What company makes MTR550 (Tentative) Antimicrobial Silver Wound Gel?

MTR550 (Tentative) Antimicrobial Silver Wound Gel is manufactured by Medical Technology Research, Inc..

What is the FDA product code for MTR550 (Tentative) Antimicrobial Silver Wound Gel?

The FDA product code for MTR550 (Tentative) Antimicrobial Silver Wound Gel is FRO. This falls under the Anesthesiology category.

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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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