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FDA 510(k)

TROPAZONE LOTION

K-Number: K090337 · 2009-08-13

ApplicantMidlothian Laboratories
Decision Date2009-08-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TROPAZONE LOTION is the device name listed in this FDA 510(k) record. The listed applicant is Midlothian Laboratories. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K090337. 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 TROPAZONE LOTION?

TROPAZONE LOTION is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Midlothian Laboratories. The 510(k) number is K090337.

When did TROPAZONE LOTION receive FDA 510(k) clearance?

TROPAZONE LOTION received FDA 510(k) clearance on 2009-08-13, under 510(k) number K090337.

Who is the listed applicant for TROPAZONE LOTION?

The FDA 510(k) record lists Midlothian Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROPAZONE LOTION?

The FDA product code for TROPAZONE LOTION is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Midlothian Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093544TROPAZONE CR

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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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