FDA 510(k)

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K-번호: K160877 · 2016-05-20

결정일2016-05-20

제품 코드KOD

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

United Urologics Closed System Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Robling Medical, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160877. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the United Urologics Closed System Catheter?

United Urologics Closed System Catheter is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Robling Medical, Inc.. The 510(k) number is K160877.

When did United Urologics Closed System Catheter receive FDA 510(k) clearance?

United Urologics Closed System Catheter received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160877.

Who is the listed applicant for United Urologics Closed System Catheter?

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

What is the FDA product code for United Urologics Closed System Catheter?

The FDA product code for United Urologics Closed System Catheter is KOD.

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기기 요약

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관련 임상시험

관련 기기 (코드: KOD)

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