FDA 510(k)

Lenstec LC Injection system

Número K: K161776 · 2016-11-29

Data da decisão2016-11-29

Código do produtoMSS

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lenstec LC Injection system is the device name listed in this FDA 510(k) record. The listed applicant is Lenstec, Inc.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) number K161776. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lenstec LC Injection system?

Lenstec LC Injection system is a medical device that received FDA 510(k) clearance on 2016-11-29. The listed applicant is Lenstec, Inc.. The 510(k) number is K161776.

When did Lenstec LC Injection system receive FDA 510(k) clearance?

Lenstec LC Injection system received FDA 510(k) clearance on 2016-11-29, under 510(k) number K161776.

Who is the listed applicant for Lenstec LC Injection system?

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

What is the FDA product code for Lenstec LC Injection system?

The FDA product code for Lenstec LC Injection system is MSS.

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