FDA 510(k)

DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY

K-Number: K080315 · 2008-04-23

Decision Date2008-04-23

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA 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 2008-04-23 under 510(k) number K080315. 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 DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY?

DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Derma Sciences, Inc.. The 510(k) number is K080315.

When did DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY receive FDA 510(k) clearance?

DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080315.

Who is the listed applicant for DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA 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 DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY?

The FDA product code for DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY is FRO. This falls under the Anesthesiology category.

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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.