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FDA 510(k)

NIXALL TM WOUND AND SKIN CARE

K-Number: K113693 · 2012-12-11

ApplicantSeriously Clean, Ltd.
Decision Date2012-12-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NIXALL TM WOUND AND SKIN CARE is the device name listed in this FDA 510(k) record. The listed applicant is Seriously Clean, Ltd.. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K113693. 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 NIXALL TM WOUND AND SKIN CARE?

NIXALL TM WOUND AND SKIN CARE is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Seriously Clean, Ltd.. The 510(k) number is K113693.

When did NIXALL TM WOUND AND SKIN CARE receive FDA 510(k) clearance?

NIXALL TM WOUND AND SKIN CARE received FDA 510(k) clearance on 2012-12-11, under 510(k) number K113693.

Who is the listed applicant for NIXALL TM WOUND AND SKIN CARE?

The FDA 510(k) record lists Seriously Clean, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIXALL TM WOUND AND SKIN CARE?

The FDA product code for NIXALL TM WOUND AND SKIN CARE 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 Seriously Clean, Ltd. 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.

K243457Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel

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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