FDA 510(k)

BioSphere MIS Putty (BioSphere MIS)

Número K: K173301 · 2018-01-19

Data da decisão2018-01-19

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioSphere MIS Putty (BioSphere MIS) is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Biomedical, LLC. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173301. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioSphere MIS Putty (BioSphere MIS)?

BioSphere MIS Putty (BioSphere MIS) is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Synergy Biomedical, LLC. The 510(k) number is K173301.

When did BioSphere MIS Putty (BioSphere MIS) receive FDA 510(k) clearance?

BioSphere MIS Putty (BioSphere MIS) received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173301.

Who is the listed applicant for BioSphere MIS Putty (BioSphere MIS)?

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

What is the FDA product code for BioSphere MIS Putty (BioSphere MIS)?

The FDA product code for BioSphere MIS Putty (BioSphere MIS) is MQV.

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