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FDA 510(k)

GaltTWS

K-Number: K182660 · 2019-05-30

ApplicantGalt Medical Corp.
Decision Date2019-05-30
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GaltTWS is a medical device manufactured by Galt Medical Corp.. It received FDA 510(k) clearance on 2019-05-30 under approval number K182660. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GaltTWS?

GaltTWS is a medical device that received FDA 510(k) clearance on 2019-05-30. It is manufactured by Galt Medical Corp.. The 510(k) number is K182660.

When was GaltTWS approved by the FDA?

GaltTWS received FDA 510(k) clearance on 2019-05-30, under approval number K182660.

What company makes GaltTWS?

GaltTWS is manufactured by Galt Medical Corp..

What is the FDA product code for GaltTWS?

The FDA product code for GaltTWS is DRB.

Other Devices by Galt Medical Corp.

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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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