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FDA 510(k)

LT Antibacterial Alginate with Silver Dressing

K-Number: K192478 · 2020-06-17

ApplicantZhejiang Longterm Medical Technology Co., Ltd.
Decision Date2020-06-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LT Antibacterial Alginate with Silver Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192478. 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 LT Antibacterial Alginate with Silver Dressing?

LT Antibacterial Alginate with Silver Dressing is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K192478.

When did LT Antibacterial Alginate with Silver Dressing receive FDA 510(k) clearance?

LT Antibacterial Alginate with Silver Dressing received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192478.

Who is the listed applicant for LT Antibacterial Alginate with Silver Dressing?

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

What is the FDA product code for LT Antibacterial Alginate with Silver Dressing?

The FDA product code for LT Antibacterial Alginate with Silver Dressing is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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NCT07758855Nanotechnological Silver-Coated Dressing in Diabetic Foot UlcersCOMPLETED

Other records listing Zhejiang Longterm Medical Technology 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.

K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitK202823Innomed NPWT Silicone Foam DressingK182458Longterm NPWT Foam Dressing Kit

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

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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