FDA 510(k)

超SEP

K号: K210945 · 2021-07-08

决定日期2021-07-08

产品代码KLE

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决定实质等同

器械摘要

Ultra SEP is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K210945. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultra SEP?

Ultra SEP is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K210945.

When did Ultra SEP receive FDA 510(k) clearance?

Ultra SEP received FDA 510(k) clearance on 2021-07-08, under 510(k) number K210945.

Who is the listed applicant for Ultra SEP?

The FDA 510(k) record lists Reliance Orthodontic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultra SEP?

The FDA product code for Ultra SEP is KLE.

列明Reliance Orthodontic Products, Inc.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。

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