FDA 510(k)

Stryker儿童下颌骨分离器2

K号: K181504 · 2018-09-11

决定日期2018-09-11

产品代码MQN

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决定实质等同

器械摘要

Stryker Pediatric Mandibular Distractor 2 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K181504. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stryker Pediatric Mandibular Distractor 2?

Stryker Pediatric Mandibular Distractor 2 is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Stryker. The 510(k) number is K181504.

When did Stryker Pediatric Mandibular Distractor 2 receive FDA 510(k) clearance?

Stryker Pediatric Mandibular Distractor 2 received FDA 510(k) clearance on 2018-09-11, under 510(k) number K181504.

Who is the listed applicant for Stryker Pediatric Mandibular Distractor 2?

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

What is the FDA product code for Stryker Pediatric Mandibular Distractor 2?

The FDA product code for Stryker Pediatric Mandibular Distractor 2 is MQN.

列明Stryker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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