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FDA 510(k)

LeEject 2 Dental Syringe and Needle System

Número K: K171254 · 2017-11-16

RequerenteAdvanced Technology and Capital, Inc.
Data da decisão2017-11-16
Código do produtoEJI
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

LeEject 2 Dental Syringe and Needle System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology and Capital, Inc.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K171254. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LeEject 2 Dental Syringe and Needle System?

LeEject 2 Dental Syringe and Needle System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Advanced Technology and Capital, Inc.. The 510(k) number is K171254.

When did LeEject 2 Dental Syringe and Needle System receive FDA 510(k) clearance?

LeEject 2 Dental Syringe and Needle System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K171254.

Who is the listed applicant for LeEject 2 Dental Syringe and Needle System?

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

What is the FDA product code for LeEject 2 Dental Syringe and Needle System?

The FDA product code for LeEject 2 Dental Syringe and Needle System is EJI.

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Fonte oficial

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