Avance腹部敷料套装
K号: K161939 · 2016-11-17
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决定日期2016-11-17
产品代码OXJ
咨询委员会SU
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器械摘要
Avance Abdominal Dressing Kit 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 2016-11-17 under 510(k) number K161939. The device is classified under product code OXJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Avance Abdominal Dressing Kit?
Avance Abdominal Dressing Kit is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K161939.
When did Avance Abdominal Dressing Kit receive FDA 510(k) clearance?
Avance Abdominal Dressing Kit received FDA 510(k) clearance on 2016-11-17, under 510(k) number K161939.
Who is the listed applicant for Avance Abdominal Dressing Kit?
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 Abdominal Dressing Kit?
The FDA product code for Avance Abdominal Dressing Kit is OXJ.
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 MicroK191869Biogel(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
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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