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FDA 510(k)

Atteris Antimicrobial Skin Protectant

K-Number: K161212 · 2016-09-30

ApplicantRochal Industries, LLC
Decision Date2016-09-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Atteris Antimicrobial Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161212. 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 Atteris Antimicrobial Skin Protectant?

Atteris Antimicrobial Skin Protectant is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Rochal Industries, LLC. The 510(k) number is K161212.

When did Atteris Antimicrobial Skin Protectant receive FDA 510(k) clearance?

Atteris Antimicrobial Skin Protectant received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161212.

Who is the listed applicant for Atteris Antimicrobial Skin Protectant?

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

What is the FDA product code for Atteris Antimicrobial Skin Protectant?

The FDA product code for Atteris Antimicrobial Skin Protectant is FRO. This falls under the Anesthesiology category.

Other records listing Rochal Industries, LLC 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.

K192527Rochal Antimicrobial Wound GelK182733Rochal Bioshield Silicone FilmK160192Atteris Antimicrobial Skin & Wound CleanserK160684Atteris No-Sting Skin Protectant

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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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