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FDA 510(k)

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%

K-Number: K090791 · 2009-08-07

ApplicantCentury Pharmaceuticals, Inc.
Decision Date2009-08-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% is the device name listed in this FDA 510(k) record. The listed applicant is Century Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K090791. 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 DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Century Pharmaceuticals, Inc.. The 510(k) number is K090791.

When did DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% receive FDA 510(k) clearance?

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% received FDA 510(k) clearance on 2009-08-07, under 510(k) number K090791.

Who is the listed applicant for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

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

What is the FDA product code for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

The FDA product code for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% is FRO. This falls under the Anesthesiology category.

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Other records listing Century Pharmaceuticals, Inc. 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.

K150208Dakin's Skin and Wound Cleanser

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

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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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