FDA 510(k)

Puritan 粪便 Opti-Swab 收集和运输系统

K号: K162284 · 2016-11-04

决定日期2016-11-04

产品代码JSM

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决定实质等同

器械摘要

Puritan Fecal Opti-Swab Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162284. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Puritan Fecal Opti-Swab Collection and Transport System?

Puritan Fecal Opti-Swab Collection and Transport System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Puritan Medical Products, LLC. The 510(k) number is K162284.

When did Puritan Fecal Opti-Swab Collection and Transport System receive FDA 510(k) clearance?

Puritan Fecal Opti-Swab Collection and Transport System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162284.

Who is the listed applicant for Puritan Fecal Opti-Swab Collection and Transport System?

The FDA 510(k) record lists Puritan Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Puritan Fecal Opti-Swab Collection and Transport System?

The FDA product code for Puritan Fecal Opti-Swab Collection and Transport System is JSM.

列明Puritan Medical Products, LLC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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