FDA 510(k)

All-Bond Universal w/BAC (not finalized)

K号: K161051 · 2016-09-09

决定日期2016-09-09

产品代码KLE

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决定实质等同

器械摘要

All-Bond Universal w/BAC (not finalized) is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161051. 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 All-Bond Universal w/BAC (not finalized)?

All-Bond Universal w/BAC (not finalized) is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Bisco, Inc.. The 510(k) number is K161051.

When did All-Bond Universal w/BAC (not finalized) receive FDA 510(k) clearance?

All-Bond Universal w/BAC (not finalized) received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161051.

Who is the listed applicant for All-Bond Universal w/BAC (not finalized)?

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

What is the FDA product code for All-Bond Universal w/BAC (not finalized)?

The FDA product code for All-Bond Universal w/BAC (not finalized) is KLE.

列明Bisco, 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。

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