FDA 510(k)

ECT棉咬合块-大号，ECT棉咬合块-中号

K号: K201309 · 2021-06-04

决定日期2021-06-04

产品代码JXL

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决定实质等同

器械摘要

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is the device name listed in this FDA 510(k) record. The listed applicant is Mecta Corporation. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K201309. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Mecta Corporation. The 510(k) number is K201309.

When did ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium receive FDA 510(k) clearance?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium received FDA 510(k) clearance on 2021-06-04, under 510(k) number K201309.

Who is the listed applicant for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

The FDA 510(k) record lists Mecta Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

The FDA product code for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is JXL.

列明Mecta Corporation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。

K192834MECTA Sigma

官方来源

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