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FDA 510(k)

Silverlon Wound Contact, Burn Contact Dressings

K-Number: K221218 · 2022-10-26

ApplicantArgentum Medical, Inc.
Decision Date2022-10-26
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Silverlon Wound Contact, Burn Contact Dressings is a medical device manufactured by Argentum Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under approval number K221218. 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 Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Argentum Medical, Inc.. The 510(k) number is K221218.

When was Silverlon Wound Contact, Burn Contact Dressings approved by the FDA?

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2022-10-26, under approval number K221218.

What company makes Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is manufactured by Argentum Medical, Inc..

What is the FDA product code for Silverlon Wound Contact, Burn Contact Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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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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