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FDA 510(k)

NOVATECH TALCAIR

K-Number: K151832 · 2016-03-31

ApplicantNovatech SA
Decision Date2016-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NOVATECH TALCAIR is a medical device manufactured by Novatech SA. It received FDA 510(k) clearance on 2016-03-31 under approval number K151832. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATECH TALCAIR?

NOVATECH TALCAIR is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Novatech SA. The 510(k) number is K151832.

When was NOVATECH TALCAIR approved by the FDA?

NOVATECH TALCAIR received FDA 510(k) clearance on 2016-03-31, under approval number K151832.

What company makes NOVATECH TALCAIR?

NOVATECH TALCAIR is manufactured by Novatech SA.

What is the FDA product code for NOVATECH TALCAIR?

The FDA product code for NOVATECH TALCAIR is GCJ.

Other Devices by Novatech SA

K170030NOVATECH TALCAIR K243126TRACHEOBRONXANE™ DUMON® K242324DUTAU-NOVATECH®

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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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