FDA 510(k)

MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY

K-Number: K110546 · 2011-07-27

Decision Date2011-07-27

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY is the device name listed in this FDA 510(k) record. The listed applicant is Derma Sciences, Inc.. It received FDA 510(k) clearance on 2011-07-27 under 510(k) number K110546. 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 MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY?

MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY is a medical device that received FDA 510(k) clearance on 2011-07-27. The listed applicant is Derma Sciences, Inc.. The 510(k) number is K110546.

When did MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY receive FDA 510(k) clearance?

MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY received FDA 510(k) clearance on 2011-07-27, under 510(k) number K110546.

Who is the listed applicant for MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY?

The FDA 510(k) record lists Derma Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY?

The FDA product code for MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY is FRO. This falls under the Anesthesiology category.

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Other records listing Derma Sciences, Inc. as applicant

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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.