FDA 510(k)

C-30 Crown Kit

K号: K211345 · 2021-11-24

决定日期2021-11-24

产品代码EBF

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决定实质等同

器械摘要

C-30 Crown Kit is the device name listed in this FDA 510(k) record. The listed applicant is Perfect Fit Crowns, LLC. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K211345. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the C-30 Crown Kit?

C-30 Crown Kit is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Perfect Fit Crowns, LLC. The 510(k) number is K211345.

When did C-30 Crown Kit receive FDA 510(k) clearance?

C-30 Crown Kit received FDA 510(k) clearance on 2021-11-24, under 510(k) number K211345.

Who is the listed applicant for C-30 Crown Kit?

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

What is the FDA product code for C-30 Crown Kit?

The FDA product code for C-30 Crown Kit is EBF.

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。

C-30 Crown Kit

器械摘要

常见问题

相关临床试验

相关器械（代码：EBF）

官方来源