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FDA 510(k)

SURECELL Gelling Fiber Wound Dressing

K-Number: K173005 · 2018-05-25

ApplicantJiangsu Newvalue Medical Producst Co.,Ltd
Decision Date2018-05-25
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SURECELL Gelling Fiber Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Newvalue Medical Producst Co.,Ltd. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K173005. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURECELL Gelling Fiber Wound Dressing?

SURECELL Gelling Fiber Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Jiangsu Newvalue Medical Producst Co.,Ltd. The 510(k) number is K173005.

When did SURECELL Gelling Fiber Wound Dressing receive FDA 510(k) clearance?

SURECELL Gelling Fiber Wound Dressing received FDA 510(k) clearance on 2018-05-25, under 510(k) number K173005.

Who is the listed applicant for SURECELL Gelling Fiber Wound Dressing?

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

What is the FDA product code for SURECELL Gelling Fiber Wound Dressing?

The FDA product code for SURECELL Gelling Fiber Wound Dressing is KGN.

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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