FDA 510(k)

MESIRE - Balloon Sinus Dilatation System

Número K: K172737 · 2017-12-12

RequerenteM/S. Meril Life Sciences Private Limited

Data da decisão2017-12-12

Código do produtoLRC

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

MESIRE - Balloon Sinus Dilatation System is the device name listed in this FDA 510(k) record. The listed applicant is M/S. Meril Life Sciences Private Limited. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K172737. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MESIRE - Balloon Sinus Dilatation System?

MESIRE - Balloon Sinus Dilatation System is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is M/S. Meril Life Sciences Private Limited. The 510(k) number is K172737.

When did MESIRE - Balloon Sinus Dilatation System receive FDA 510(k) clearance?

MESIRE - Balloon Sinus Dilatation System received FDA 510(k) clearance on 2017-12-12, under 510(k) number K172737.

Who is the listed applicant for MESIRE - Balloon Sinus Dilatation System?

The FDA 510(k) record lists M/S. Meril Life Sciences Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESIRE - Balloon Sinus Dilatation System?

The FDA product code for MESIRE - Balloon Sinus Dilatation System is LRC.

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