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FDA 510(k)

SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD

K-Number: K984208 · 1999-02-22

ApplicantArgentum International, LLC
Decision Date1999-02-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD 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 1999-02-22 under 510(k) number K984208. 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 ISLAND DRESSING, SILVERLON ISLAND PAD?

SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD is a medical device that received FDA 510(k) clearance on 1999-02-22. The listed applicant is Argentum International, LLC. The 510(k) number is K984208.

When did SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD receive FDA 510(k) clearance?

SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD received FDA 510(k) clearance on 1999-02-22, under 510(k) number K984208.

Who is the listed applicant for SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD?

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 ISLAND DRESSING, SILVERLON ISLAND PAD?

The FDA product code for SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD 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 DRESSINGK023609SILVERLON ADHESIVE STRIPK984210SILVERLON WOUND PACKING STRIPS

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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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