XLR8 腹部伤口敷料套装
K号: K182722 · 2019-09-27
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决定日期2019-09-27
产品代码OMP
咨询委员会SU
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决定实质等同
器械摘要
XLR8 Abdominal Wound Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K182722. 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 XLR8 Abdominal Wound Dressing Kit?
XLR8 Abdominal Wound Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Genadyne Biotechnologies. The 510(k) number is K182722.
When did XLR8 Abdominal Wound Dressing Kit receive FDA 510(k) clearance?
XLR8 Abdominal Wound Dressing Kit received FDA 510(k) clearance on 2019-09-27, under 510(k) number K182722.
Who is the listed applicant for XLR8 Abdominal Wound Dressing Kit?
The FDA 510(k) record lists Genadyne Biotechnologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XLR8 Abdominal Wound Dressing Kit?
The FDA product code for XLR8 Abdominal Wound Dressing Kit is OMP.
相关临床试验
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列明Genadyne Biotechnologies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。
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
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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