FDA 510(k)

VersaWrap

K号: K213163 · 2021-10-29

决定日期2021-10-29

产品代码FTM

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决定实质等同

器械摘要

VersaWrap is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K213163. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VersaWrap?

VersaWrap is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K213163.

When did VersaWrap receive FDA 510(k) clearance?

VersaWrap received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213163.

Who is the listed applicant for VersaWrap?

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

What is the FDA product code for VersaWrap?

The FDA product code for VersaWrap is FTM.

列明Alafair Biosciences, 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。

K240817VersaWrap K232029VersaWrap 神经保护器 K203600VersaWrap K201631VersaWrap 神经保护器 K200311VersaWrap 腱保护器 K160364VersaWrap 腱保护器

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官方来源

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