LUOFUCON® 胶原颗粒（胶原蛋白伤口敷料）
K号: K232796 · 2024-04-25
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器械摘要
LUOFUCON® Collagen Particles (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 2024-04-25 under 510(k) number K232796. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
常见问题
What is the LUOFUCON® Collagen Particles (Collagen Wound Dressing)?
LUOFUCON® Collagen Particles (Collagen Wound Dressing) is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K232796.
When did LUOFUCON® Collagen Particles (Collagen Wound Dressing) receive FDA 510(k) clearance?
LUOFUCON® Collagen Particles (Collagen Wound Dressing) received FDA 510(k) clearance on 2024-04-25, under 510(k) number K232796.
Who is the listed applicant for LUOFUCON® Collagen Particles (Collagen Wound Dressing)?
FDA 510(k)记录将惠州友康医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for LUOFUCON® Collagen Particles (Collagen Wound Dressing)?
The FDA product code for LUOFUCON® Collagen Particles (Collagen Wound Dressing) is KGN.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Huizhou Foryou Medical Devices Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：KGN）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced BiomaterialsK260596胶原蛋白伤口粉Ventris MedicalK260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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