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FDA 510(k)

MESIRE - Balloon Sinus Dilatation System

K-Number: K172737 · 2017-12-12

ApplicantM/S. Meril Life Sciences Private Limited
Decision Date2017-12-12
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by M/S. Meril Life Sciences Private Limited. The 510(k) number is K172737.

When was MESIRE - Balloon Sinus Dilatation System approved by the FDA?

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

What company makes MESIRE - Balloon Sinus Dilatation System?

MESIRE - Balloon Sinus Dilatation System is manufactured by M/S. Meril Life Sciences Private Limited.

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

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

Related Clinical Trials

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Related Devices (Code: LRC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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