FDA 510(k)

X-Y 润滑凝胶

K号: K220226 · 2023-03-28

决定日期2023-03-28

产品代码NUC

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决定实质等同

器械摘要

X-Y Lubricating Jelly is the device name listed in this FDA 510(k) record. The listed applicant is R&R Medical Corporation, Ltd.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K220226. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-Y Lubricating Jelly?

X-Y Lubricating Jelly is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is R&R Medical Corporation, Ltd.. The 510(k) number is K220226.

When did X-Y Lubricating Jelly receive FDA 510(k) clearance?

X-Y Lubricating Jelly received FDA 510(k) clearance on 2023-03-28, under 510(k) number K220226.

Who is the listed applicant for X-Y Lubricating Jelly?

The FDA 510(k) record lists R&R Medical Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-Y Lubricating Jelly?

The FDA product code for X-Y Lubricating Jelly is NUC.

列明R&R Medical Corporation, Ltd.为申报人的其他记录

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