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FDA 510(k)

X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING

K-Number: K033900 · 2005-01-14

ApplicantNoble Fiber Technologies
Decision Date2005-01-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING 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 2005-01-14 under 510(k) number K033900. 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 X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING?

X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 2005-01-14. The listed applicant is Noble Fiber Technologies. The 510(k) number is K033900.

When did X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING receive FDA 510(k) clearance?

X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING received FDA 510(k) clearance on 2005-01-14, under 510(k) number K033900.

Who is the listed applicant for X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING?

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 X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING?

The FDA product code for X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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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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.

K033587SILVERSEALK040019SILVERSEAL

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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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