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FDA 510(k)

ISLAND WOUND DRESSING WITH MICROBAN

K-Number: K010951 · 2001-06-11

ApplicantIsland Dressing, LLC
Decision Date2001-06-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ISLAND WOUND DRESSING WITH MICROBAN is the device name listed in this FDA 510(k) record. The listed applicant is Island Dressing, LLC. It received FDA 510(k) clearance on 2001-06-11 under 510(k) number K010951. 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 ISLAND WOUND DRESSING WITH MICROBAN?

ISLAND WOUND DRESSING WITH MICROBAN is a medical device that received FDA 510(k) clearance on 2001-06-11. The listed applicant is Island Dressing, LLC. The 510(k) number is K010951.

When did ISLAND WOUND DRESSING WITH MICROBAN receive FDA 510(k) clearance?

ISLAND WOUND DRESSING WITH MICROBAN received FDA 510(k) clearance on 2001-06-11, under 510(k) number K010951.

Who is the listed applicant for ISLAND WOUND DRESSING WITH MICROBAN?

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

What is the FDA product code for ISLAND WOUND DRESSING WITH MICROBAN?

The FDA product code for ISLAND WOUND DRESSING WITH MICROBAN is FRO. This falls under the Anesthesiology category.

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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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