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FDA 510(k)

ALGS6 Ag Alginate Wound Dressing

K-Number: K172570 · 2018-05-11

ApplicantFoshan United Medical Technologies, Ltd.
Decision Date2018-05-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ALGS6 Ag Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Foshan United Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K172570. 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 ALGS6 Ag Alginate Wound Dressing?

ALGS6 Ag Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Foshan United Medical Technologies, Ltd.. The 510(k) number is K172570.

When did ALGS6 Ag Alginate Wound Dressing receive FDA 510(k) clearance?

ALGS6 Ag Alginate Wound Dressing received FDA 510(k) clearance on 2018-05-11, under 510(k) number K172570.

Who is the listed applicant for ALGS6 Ag Alginate Wound Dressing?

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

What is the FDA product code for ALGS6 Ag Alginate Wound Dressing?

The FDA product code for ALGS6 Ag Alginate Wound Dressing is FRO. This falls under the Anesthesiology category.

Other records listing Foshan United Medical Technologies, 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.

K233111ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

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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