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FDA 510(k)

SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)

K-Number: K090254 · 2009-09-04

ApplicantConvatec, A Division of E.R. Squibb & Sons, LLC
Decision Date2009-09-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons, LLC. It received FDA 510(k) clearance on 2009-09-04 under 510(k) number K090254. 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 SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)?

SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) is a medical device that received FDA 510(k) clearance on 2009-09-04. The listed applicant is Convatec, A Division of E.R. Squibb & Sons, LLC. The 510(k) number is K090254.

When did SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) receive FDA 510(k) clearance?

SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) received FDA 510(k) clearance on 2009-09-04, under 510(k) number K090254.

Who is the listed applicant for SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)?

The FDA product code for SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) is FRO. This falls under the Anesthesiology category.

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Other records listing Convatec, A Division of E.R. Squibb & Sons, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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