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FDA 510(k)

INT Contour

K号: K212274 · 2022-04-08

决定日期2022-04-08
产品代码MUJ
咨询委员会RA
决定实质等同

器械摘要

INT Contour is the device name listed in this FDA 510(k) record. The listed applicant is Carina Medical, LLC. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K212274. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the INT Contour?

INT Contour is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Carina Medical, LLC. The 510(k) number is K212274.

When did INT Contour receive FDA 510(k) clearance?

INT Contour received FDA 510(k) clearance on 2022-04-08, under 510(k) number K212274.

Who is the listed applicant for INT Contour?

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

What is the FDA product code for INT Contour?

The FDA product code for INT Contour is MUJ.

相关临床试验

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列明Carina Medical, LLC为申报人的其他记录

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相关器械(代码:MUJ)

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官方来源

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