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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 a medical device manufactured by Rochal Industries, LLC. It received FDA 510(k) clearance on 2016-09-30 under approval 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. It is manufactured by Rochal Industries, LLC. The 510(k) number is K161212.

When was Atteris Antimicrobial Skin Protectant approved by the FDA?

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

What company makes Atteris Antimicrobial Skin Protectant?

Atteris Antimicrobial Skin Protectant is manufactured by Rochal Industries, LLC.

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 Devices by Rochal Industries, LLC

K160192Atteris Antimicrobial Skin & Wound Cleanser K160684Atteris No-Sting Skin Protectant K182733Rochal Bioshield Silicone Film K192527Rochal Antimicrobial Wound Gel

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K153565DONASORB SILVER WOUND DRESSINGVirchow Biotech Pvt, Ltd.

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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