FDA 510(k)

LensGiene Sterile Saline Solution

Номер K: K161622 · 2016-08-11

Дата решения2016-08-11

Код продуктаLPN

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

LensGiene Sterile Saline Solution is the device name listed in this FDA 510(k) record. The listed applicant is Optics Laboratory, Inc.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K161622. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the LensGiene Sterile Saline Solution?

LensGiene Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Optics Laboratory, Inc.. The 510(k) number is K161622.

When did LensGiene Sterile Saline Solution receive FDA 510(k) clearance?

LensGiene Sterile Saline Solution received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161622.

Who is the listed applicant for LensGiene Sterile Saline Solution?

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

What is the FDA product code for LensGiene Sterile Saline Solution?

The FDA product code for LensGiene Sterile Saline Solution is LPN.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LPN)

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, Incorporated K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K202932ABT12 многофункциональный растворBausch & Lomb, Incorporated K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC K193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.

Официальный источник

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