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FDA 510(k)

LUOFUCON Collagen Wound Dressing

K-Number: K213598 · 2022-09-20

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2022-09-20
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

LUOFUCON Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K213598. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUOFUCON Collagen Wound Dressing?

LUOFUCON Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K213598.

When did LUOFUCON Collagen Wound Dressing receive FDA 510(k) clearance?

LUOFUCON Collagen Wound Dressing received FDA 510(k) clearance on 2022-09-20, under 510(k) number K213598.

Who is the listed applicant for LUOFUCON Collagen Wound Dressing?

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

What is the FDA product code for LUOFUCON Collagen Wound Dressing?

The FDA product code for LUOFUCON Collagen Wound Dressing is KGN.

Related Clinical Trials

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.

NCT07409571Palatal Wound Healing After Free Gingival Graft SurgeryRECRUITING

Other records listing Huizhou Foryou Medical Devices 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.

K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K240809LUOFUCON® Silver Collagen DressingK242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

View all 17 devices →

Related Devices (Code: KGN)

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., 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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