FDA 510(k)

MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY

K-Number: K101793 · 2011-02-22

Decision Date2011-02-22

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

MEDIHONEY GEL DRESSING 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 2011-02-22 under 510(k) number K101793. 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 GEL DRESSING WITH ACTIVE MANUKA HONEY?

MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY is a medical device that received FDA 510(k) clearance on 2011-02-22. The listed applicant is Derma Sciences, Inc.. The 510(k) number is K101793.

When did MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY receive FDA 510(k) clearance?

MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY received FDA 510(k) clearance on 2011-02-22, under 510(k) number K101793.

Who is the listed applicant for MEDIHONEY GEL DRESSING 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 MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY?

The FDA product code for MEDIHONEY GEL DRESSING 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.