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FDA 510(k)

Roosin Xeroform Petrolatum Dressing

K-Number: K181478 · 2019-09-13

ApplicantRoosin Medical Co., Ltd.
Decision Date2019-09-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Roosin Xeroform Petrolatum Dressing is a medical device manufactured by Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-13 under approval number K181478. 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 Roosin Xeroform Petrolatum Dressing?

Roosin Xeroform Petrolatum Dressing is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Roosin Medical Co., Ltd.. The 510(k) number is K181478.

When was Roosin Xeroform Petrolatum Dressing approved by the FDA?

Roosin Xeroform Petrolatum Dressing received FDA 510(k) clearance on 2019-09-13, under approval number K181478.

What company makes Roosin Xeroform Petrolatum Dressing?

Roosin Xeroform Petrolatum Dressing is manufactured by Roosin Medical Co., Ltd..

What is the FDA product code for Roosin Xeroform Petrolatum Dressing?

The FDA product code for Roosin Xeroform Petrolatum Dressing is FRO. This falls under the Anesthesiology category.

Other Devices by Roosin Medical Co., Ltd.

K230190Polyver Silver Alginate Dressing (Prescription and OTC) K231088Copper Foam Dressing (Prescription and OTC)

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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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