FDA 510(k)

Parkell 通用粘合剂

K号: K172176 · 2017-11-21

决定日期2017-11-21

产品代码KLE

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决定实质等同

器械摘要

Parkell Universal Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K172176. 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 Parkell Universal Adhesive?

Parkell Universal Adhesive is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Parkell, Inc.. The 510(k) number is K172176.

When did Parkell Universal Adhesive receive FDA 510(k) clearance?

Parkell Universal Adhesive received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172176.

Who is the listed applicant for Parkell Universal Adhesive?

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

What is the FDA product code for Parkell Universal Adhesive?

The FDA product code for Parkell Universal Adhesive is KLE.

列明Parkell, 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。

K243254Parkell 龋齿和裂隙封闭剂 K210259Parkell 自粘性水泥 K191103Parkell 感觉丧失凝胶 K190930SmarTemp X1 K182296HyperFil-LV

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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。