FDA 510(k)

PREVENA DUO, PREVENA PLUS DUO 切口管理系统及 PEEL & PLACE 敷料

K号: K161897 · 2016-10-04

申请人Kci USA, Inc. (Kinetic Concepts, Inc.)

决定日期2016-10-04

产品代码OMP

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决定实质等同

器械摘要

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161897. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K161897.

When did PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings receive FDA 510(k) clearance?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161897.

Who is the listed applicant for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

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

What is the FDA product code for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

The FDA product code for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is OMP.

列明Kci USA, Inc. (Kinetic Concepts, 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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