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FDA 510(k)

Foundation Dermal Regeneration Scaffold (DRS) Solo

K号: K210949 · 2022-08-11

申请人Bionova Medical, Inc.
决定日期2022-08-11
产品代码KGN
决定实质等同

器械摘要

Foundation Dermal Regeneration Scaffold (DRS) Solo is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K210949. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Foundation Dermal Regeneration Scaffold (DRS) Solo?

Foundation Dermal Regeneration Scaffold (DRS) Solo is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K210949.

When did Foundation Dermal Regeneration Scaffold (DRS) Solo receive FDA 510(k) clearance?

Foundation Dermal Regeneration Scaffold (DRS) Solo received FDA 510(k) clearance on 2022-08-11, under 510(k) number K210949.

Who is the listed applicant for Foundation Dermal Regeneration Scaffold (DRS) Solo?

The FDA 510(k) record lists Bionova Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Foundation Dermal Regeneration Scaffold (DRS) Solo?

The FDA product code for Foundation Dermal Regeneration Scaffold (DRS) Solo 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Bionova Medical, Inc.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。

K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloK240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoK231937Foundation Dermal Regeneration Scaffold (DRS) Solo

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

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