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FDA 510(k)

Theia NPWT泡沫伤口敷料套装-小号，Theia NPWT泡沫伤口敷料套装-中号，Theia NPWT泡沫伤口敷料套装-大号

K号: K161570 · 2016-08-29

申请人Lc Medical Concepts, Inc.
决定日期2016-08-29
产品代码OMP
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决定实质等同

器械摘要

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large is the device name listed in this FDA 510(k) record. The listed applicant is Lc Medical Concepts, Inc.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161570. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large?

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Lc Medical Concepts, Inc.. The 510(k) number is K161570.

When did Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large receive FDA 510(k) clearance?

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161570.

Who is the listed applicant for Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large?

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

What is the FDA product code for Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large?

The FDA product code for Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large is OMP.

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

相关器械（代码：OMP）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 负压伤口治疗系统Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 罐 500-毫升 (CPC-500)Cork MedicalK254019伤口基因NPWT系统Bechtel Medical, Inc.

官方来源

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