FDA 510(k)

Roosin Xeroform Petrolatum Dressing

K-Number: K181478 · 2019-09-13

Decision Date2019-09-13

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Roosin Xeroform Petrolatum Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) 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. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K181478.

When did Roosin Xeroform Petrolatum Dressing receive FDA 510(k) clearance?

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

Who is the listed applicant for Roosin Xeroform Petrolatum Dressing?

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

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 records listing Roosin Medical Co., 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.

K254034Roosin Collagen Powder K253974Roosin Collagen Dressing K231088Copper Foam Dressing (Prescription and OTC)K230190Polyver Silver Alginate Dressing (Prescription and OTC)

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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.