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FDA 510(k)

SILVERSEAL

K-Number: K033587 · 2004-08-05

ApplicantNoble Fiber Technologies
Decision Date2004-08-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERSEAL is the device name listed in this FDA 510(k) record. The listed applicant is Noble Fiber Technologies. It received FDA 510(k) clearance on 2004-08-05 under 510(k) number K033587. 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 SILVERSEAL?

SILVERSEAL is a medical device that received FDA 510(k) clearance on 2004-08-05. The listed applicant is Noble Fiber Technologies. The 510(k) number is K033587.

When did SILVERSEAL receive FDA 510(k) clearance?

SILVERSEAL received FDA 510(k) clearance on 2004-08-05, under 510(k) number K033587.

Who is the listed applicant for SILVERSEAL?

The FDA 510(k) record lists Noble Fiber Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERSEAL?

The FDA product code for SILVERSEAL is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Noble Fiber Technologies 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.

K033900X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSINGK040019SILVERSEAL

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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