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FDA 510(k)

DEXERYL CREAM

K-Number: K113807 · 2012-03-07

ApplicantPierre Fabre Medical Devices
Decision Date2012-03-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DEXERYL CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Pierre Fabre Medical Devices. It received FDA 510(k) clearance on 2012-03-07 under 510(k) number K113807. 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 DEXERYL CREAM?

DEXERYL CREAM is a medical device that received FDA 510(k) clearance on 2012-03-07. The listed applicant is Pierre Fabre Medical Devices. The 510(k) number is K113807.

When did DEXERYL CREAM receive FDA 510(k) clearance?

DEXERYL CREAM received FDA 510(k) clearance on 2012-03-07, under 510(k) number K113807.

Who is the listed applicant for DEXERYL CREAM?

The FDA 510(k) record lists Pierre Fabre Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXERYL CREAM?

The FDA product code for DEXERYL CREAM is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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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