FDA 510(k)

Synvaza 口腔溃疡和伤口冲洗剂，Synvaza II 口腔溃疡和伤口冲洗剂

K号: K193336 · 2020-05-27

决定日期2020-05-27

产品代码OLR

决定实质等同

器械摘要

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Synedgen, Inc.. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K193336. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

常见问题

What is the Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Synedgen, Inc.. The 510(k) number is K193336.

When did Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse receive FDA 510(k) clearance?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse received FDA 510(k) clearance on 2020-05-27, under 510(k) number K193336.

Who is the listed applicant for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

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

What is the FDA product code for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

The FDA product code for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is OLR.

列明Synedgen, 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。

K172338Catasyn Advanced Technology Wound Hydrogel

官方来源

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