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FDA 510(k)

SILVERMED ANTIMICROBIAL SILVER HYDROGEL

K-Number: K073019 · 2008-09-16

ApplicantArgentis Biomedical Incorporated
Decision Date2008-09-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERMED ANTIMICROBIAL SILVER HYDROGEL is the device name listed in this FDA 510(k) record. The listed applicant is Argentis Biomedical Incorporated. It received FDA 510(k) clearance on 2008-09-16 under 510(k) number K073019. 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 SILVERMED ANTIMICROBIAL SILVER HYDROGEL?

SILVERMED ANTIMICROBIAL SILVER HYDROGEL is a medical device that received FDA 510(k) clearance on 2008-09-16. The listed applicant is Argentis Biomedical Incorporated. The 510(k) number is K073019.

When did SILVERMED ANTIMICROBIAL SILVER HYDROGEL receive FDA 510(k) clearance?

SILVERMED ANTIMICROBIAL SILVER HYDROGEL received FDA 510(k) clearance on 2008-09-16, under 510(k) number K073019.

Who is the listed applicant for SILVERMED ANTIMICROBIAL SILVER HYDROGEL?

The FDA 510(k) record lists Argentis Biomedical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERMED ANTIMICROBIAL SILVER HYDROGEL?

The FDA product code for SILVERMED ANTIMICROBIAL SILVER HYDROGEL 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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