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FDA 510(k)

LOUTREX TOPICAL CREAM

K-Number: K120730 · 2012-09-06

ApplicantAcella Pharmaceuticals, LLC
Decision Date2012-09-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LOUTREX TOPICAL CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Acella Pharmaceuticals, LLC. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K120730. 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 LOUTREX TOPICAL CREAM?

LOUTREX TOPICAL CREAM is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Acella Pharmaceuticals, LLC. The 510(k) number is K120730.

When did LOUTREX TOPICAL CREAM receive FDA 510(k) clearance?

LOUTREX TOPICAL CREAM received FDA 510(k) clearance on 2012-09-06, under 510(k) number K120730.

Who is the listed applicant for LOUTREX TOPICAL CREAM?

The FDA 510(k) record lists Acella Pharmaceuticals, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOUTREX TOPICAL CREAM?

The FDA product code for LOUTREX TOPICAL 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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