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FDA 510(k)

meso-relle (AAL34, AAL36, AM30G)

Número K: K161255 · 2017-01-19

RequerenteBiotekne Srl
Data da decisão2017-01-19
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

meso-relle (AAL34, AAL36, AM30G) is the device name listed in this FDA 510(k) record. The listed applicant is Biotekne Srl. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161255. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the meso-relle (AAL34, AAL36, AM30G)?

meso-relle (AAL34, AAL36, AM30G) is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Biotekne Srl. The 510(k) number is K161255.

When did meso-relle (AAL34, AAL36, AM30G) receive FDA 510(k) clearance?

meso-relle (AAL34, AAL36, AM30G) received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161255.

Who is the listed applicant for meso-relle (AAL34, AAL36, AM30G)?

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

What is the FDA product code for meso-relle (AAL34, AAL36, AM30G)?

The FDA product code for meso-relle (AAL34, AAL36, AM30G) is FMI.

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