FDA 510(k)

빛문 Tissue Retractor 시스템

K-번호: K153698 · 2016-04-19

결정일2016-04-19

제품 코드ODB

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

LumenR Tissue Retractor System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenr, LLC. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153698. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LumenR Tissue Retractor System?

LumenR Tissue Retractor System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is Lumenr, LLC. The 510(k) number is K153698.

When did LumenR Tissue Retractor System receive FDA 510(k) clearance?

LumenR Tissue Retractor System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153698.

Who is the listed applicant for LumenR Tissue Retractor System?

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

What is the FDA product code for LumenR Tissue Retractor System?

The FDA product code for LumenR Tissue Retractor System is ODB.

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빛문 Tissue Retractor 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: ODB)

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