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FDA 510(k)

激光生发帽

K号: K192627 · 2019-12-13

决定日期2019-12-13
产品代码OAP
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Laser Hair Growth Cap is the device name listed in this FDA 510(k) record. The listed applicant is Shang FA Biotechnology Co.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192627. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Laser Hair Growth Cap?

Laser Hair Growth Cap is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shang FA Biotechnology Co.. The 510(k) number is K192627.

When did Laser Hair Growth Cap receive FDA 510(k) clearance?

Laser Hair Growth Cap received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192627.

Who is the listed applicant for Laser Hair Growth Cap?

The FDA 510(k) record lists Shang FA Biotechnology Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Hair Growth Cap?

The FDA product code for Laser Hair Growth Cap is OAP.

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相关器械(代码:OAP)

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