FDA 510(k)

Avance纱布敷料套装

K号: K161948 · 2016-11-03

决定日期2016-11-03

产品代码OMP

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Avance Gauze Dressing Kits is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161948. 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 Avance Gauze Dressing Kits?

Avance Gauze Dressing Kits is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K161948.

When did Avance Gauze Dressing Kits receive FDA 510(k) clearance?

Avance Gauze Dressing Kits received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161948.

Who is the listed applicant for Avance Gauze Dressing Kits?

The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avance Gauze Dressing Kits?

The FDA product code for Avance Gauze Dressing Kits is OMP.

列明Molnlycke Health Care Us, LLC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。

K232508Barrier EasyWarm 活性自加热毯 K203369Avance单负压伤口治疗（NPWT）系统 K202090Biogel Eclipse / Biogel Eclipse 指示性手套，Biogel 外科医生 / Biogel 指示性手套，Biogel PI 微型指示性手套，Biogel PI UltraTouch S 外科手套具有低皮炎潜力声明，Biogel PI UltraTouch S 指示性手套具有低皮炎潜力声明 K193573Biogel Skinsense 指示性手套，Biogel PI Ultratouch，Biogel PI 指示性手套，Biogel PI，Biogel PI Micro K191869Biogel(R) PI UltraTouch S 外科手套具有低皮炎潜力声明，Biogel(R) PI UltraTouch S 指示性手套具有低皮炎潜力声明 K190077Biogel® PI UltraTouch S 外科手套，Biogel® Pl Ultra Touch S 指示性手套

查看所有 12 个设备 →

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。