FDA 510(k)

BeneHold® 手术切口巾，含CHG抗菌剂

K号: K202208 · 2021-07-30

决定日期2021-07-30

产品代码KKX

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决定实质等同

器械摘要

BeneHold Surgical Incise Drape with CHG antimicrobial is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Belgie Bvba. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K202208. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BeneHold Surgical Incise Drape with CHG antimicrobial?

BeneHold Surgical Incise Drape with CHG antimicrobial is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Avery Dennison Belgie Bvba. The 510(k) number is K202208.

When did BeneHold Surgical Incise Drape with CHG antimicrobial receive FDA 510(k) clearance?

BeneHold Surgical Incise Drape with CHG antimicrobial received FDA 510(k) clearance on 2021-07-30, under 510(k) number K202208.

Who is the listed applicant for BeneHold Surgical Incise Drape with CHG antimicrobial?

The FDA 510(k) record lists Avery Dennison Belgie Bvba as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneHold Surgical Incise Drape with CHG antimicrobial?

The FDA product code for BeneHold Surgical Incise Drape with CHG antimicrobial is KKX.

列明Avery Dennison Belgie Bvba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。

K170407BD ChloraShield IV 敷料含CHG抗菌剂

官方来源

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