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FDA 510(k)

SILVERLON ADHESIVE STRIP

K-Number: K023609 · 2003-01-17

ApplicantArgentum International, LLC
Decision Date2003-01-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERLON ADHESIVE STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Argentum International, LLC. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K023609. 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 ADHESIVE STRIP?

SILVERLON ADHESIVE STRIP is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Argentum International, LLC. The 510(k) number is K023609.

When did SILVERLON ADHESIVE STRIP receive FDA 510(k) clearance?

SILVERLON ADHESIVE STRIP received FDA 510(k) clearance on 2003-01-17, under 510(k) number K023609.

Who is the listed applicant for SILVERLON ADHESIVE STRIP?

The FDA 510(k) record lists Argentum International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERLON ADHESIVE STRIP?

The FDA product code for SILVERLON ADHESIVE STRIP is FRO. This falls under the Anesthesiology category.

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Other records listing Argentum International, 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.

K984204SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIPK984205SILVERLON ADHESIVE STRIPK984207SILVERLON DIRECT PRESSURE WOUND DRESSINGK023612SILVERLON CONTACT WOUND DRESSINGK984210SILVERLON WOUND PACKING STRIPSK984208SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD

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Related Devices (Code: FRO)

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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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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