FDA 510(k)

ReNew Sterilization Trays(目录编号 #3708 和 #3709)

K号: K152745 · 2016-05-12

决定日期2016-05-12

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

ReNew Sterilization Trays(Catalog #3708 and #3709) is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K152745. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ReNew Sterilization Trays(Catalog #3708 and #3709)?

ReNew Sterilization Trays(Catalog #3708 and #3709) is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K152745.

When did ReNew Sterilization Trays(Catalog #3708 and #3709) receive FDA 510(k) clearance?

ReNew Sterilization Trays(Catalog #3708 and #3709) received FDA 510(k) clearance on 2016-05-12, under 510(k) number K152745.

Who is the listed applicant for ReNew Sterilization Trays(Catalog #3708 and #3709)?

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

What is the FDA product code for ReNew Sterilization Trays(Catalog #3708 and #3709)?

The FDA product code for ReNew Sterilization Trays(Catalog #3708 and #3709) is KCT.

列明Microline Surgical, Inc.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。

K234147ReNew XR 手持件，25cm，带有参考标记（3943M）；ReNew XR 手持件，34cm，带有参考标记（3941M）；ReNew XR 手持件，42cm，带有参考标记（3942M）；ReNew XR 手持件，可调节，25cm，带有参考标记（3946M）；ReNew XR 手持件，可调节，34cm，带有参考标记（3944M）；ReNew XR 手持件，可调节，42cm，带有参考标记（3945M）K213127ReNew Disposable Scissor Tips K201884ReNew XR 手柄，ReNew XR 手柄 34cm，ReNew XR 手柄 42cm，ReNew XR 手柄 25cm，可调节式 ReNew XR 手柄 34cm K160706ReNew V 手持件腹腔镜器械 K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

官方来源

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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。