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FDA 510(k)

SILVERLON CA (CALCIUM ALGINATE)

K-Number: K053590 · 2006-10-06

ApplicantArgentum Medical, LLC
Decision Date2006-10-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERLON CA (CALCIUM ALGINATE) is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, LLC. It received FDA 510(k) clearance on 2006-10-06 under 510(k) number K053590. 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 CA (CALCIUM ALGINATE)?

SILVERLON CA (CALCIUM ALGINATE) is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Argentum Medical, LLC. The 510(k) number is K053590.

When did SILVERLON CA (CALCIUM ALGINATE) receive FDA 510(k) clearance?

SILVERLON CA (CALCIUM ALGINATE) received FDA 510(k) clearance on 2006-10-06, under 510(k) number K053590.

Who is the listed applicant for SILVERLON CA (CALCIUM ALGINATE)?

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

What is the FDA product code for SILVERLON CA (CALCIUM ALGINATE)?

The FDA product code for SILVERLON CA (CALCIUM ALGINATE) is FRO. This falls under the Anesthesiology category.

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Other records listing Argentum Medical, 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.

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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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