FDA 510(k)

口腔外科对抗

K号: K211584 · 2021-08-19

决定日期2021-08-19

产品代码KMW

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决定实质等同

器械摘要

Oral Surgery Contra is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211584. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oral Surgery Contra?

Oral Surgery Contra is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Nakanishi, Inc.. The 510(k) number is K211584.

When did Oral Surgery Contra receive FDA 510(k) clearance?

Oral Surgery Contra received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211584.

Who is the listed applicant for Oral Surgery Contra?

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

What is the FDA product code for Oral Surgery Contra?

The FDA product code for Oral Surgery Contra is KMW.

列明Nakanishi, 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。

K260773Varios Combi Pro2 K254163VarioSurg 4 K252662UniBur K251689VARIOS 170 LUX 放大镜系统（VA170LUXS10）；VARIOS 170 LUX 放大镜系统（VA170LUXS11）；VARIOS 170 放大镜系统（VA170S11）K241880气动牙抛光系统（Perio-Mate）；气动牙抛光系统（Perio Mate喷嘴头）K233288NLZ Built-In Motor System

查看所有 21 个设备 →

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。