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FDA 510(k)

ELETONE CREAM

K-Number: K092297 · 2009-10-09

ApplicantFerndale Pharma Group, Inc.
Decision Date2009-10-09
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ELETONE CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Ferndale Pharma Group, Inc.. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092297. 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 ELETONE CREAM?

ELETONE CREAM is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Ferndale Pharma Group, Inc.. The 510(k) number is K092297.

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

ELETONE CREAM received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092297.

Who is the listed applicant for ELETONE CREAM?

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

What is the FDA product code for ELETONE CREAM?

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

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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.

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