FDA 510(k)

Rochal生物防护硅酮薄膜

K号: K182733 · 2019-06-27

决定日期2019-06-27

产品代码KMF

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

Rochal Bioshield Silicone Film is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K182733. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rochal Bioshield Silicone Film?

Rochal Bioshield Silicone Film is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Rochal Industries, LLC. The 510(k) number is K182733.

When did Rochal Bioshield Silicone Film receive FDA 510(k) clearance?

Rochal Bioshield Silicone Film received FDA 510(k) clearance on 2019-06-27, under 510(k) number K182733.

Who is the listed applicant for Rochal Bioshield Silicone Film?

The FDA 510(k) record lists Rochal Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rochal Bioshield Silicone Film?

The FDA product code for Rochal Bioshield Silicone Film is KMF.

列明Rochal Industries, 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。

K192527Rochal抗菌伤口凝胶 K161212Atteris 抗菌皮肤保护剂 K160192Atteris 抗菌皮肤和伤口清洁剂 K160684Atteris 无痛皮肤保护剂

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