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FDA 510(k)

NovoSorb BTM 创面敷料（2cm x 2cm），NovoSorb BTM 创面敷料（10cm x 10cm），NovoSorb BTM 创面敷料（10cm x 20cm），NovoSorb BTM 创面敷料（20cm x 40cm）

K号: K172140 · 2017-08-11

申请人Polynovo Biomaterials Pty, Ltd.
决定日期2017-08-11
产品代码QSZ
决定实质等同

器械摘要

NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) is the device name listed in this FDA 510(k) record. The listed applicant is Polynovo Biomaterials Pty, Ltd.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K172140. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常见问题

What is the NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)?

NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K172140.

When did NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) receive FDA 510(k) clearance?

NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) received FDA 510(k) clearance on 2017-08-11, under 510(k) number K172140.

Who is the listed applicant for NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)?

The FDA 510(k) record lists Polynovo Biomaterials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)?

The FDA product code for NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) is QSZ.

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Polynovo Biomaterials Pty, 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。

K251567NovoSorb BTMK242149NovoSorb® MTXK221686NovoSorb Matrix

相关器械（代码：QSZ）

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。

K261311透明质酸矩阵Anika Therapeutics, Inc.K254256LUOFUCON® 创面基质Huizhou Foryou Medical Devices Co., Ltd.K260020Redermo 伤口基质Beijing Kreate Medical Co., Ltd.K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K241660SiOxD® 创面基质Sioxmed, LLC

官方来源

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