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FDA 510(k)

Macroduct Advanced Model 3710

K-Number: K180627 · 2018-07-27

ApplicantElitechgroup, Inc.
Decision Date2018-07-27
Product CodeKTB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Macroduct Advanced Model 3710 is a medical device manufactured by Elitechgroup, Inc.. It received FDA 510(k) clearance on 2018-07-27 under approval number K180627. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Macroduct Advanced Model 3710?

Macroduct Advanced Model 3710 is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by Elitechgroup, Inc.. The 510(k) number is K180627.

When was Macroduct Advanced Model 3710 approved by the FDA?

Macroduct Advanced Model 3710 received FDA 510(k) clearance on 2018-07-27, under approval number K180627.

What company makes Macroduct Advanced Model 3710?

Macroduct Advanced Model 3710 is manufactured by Elitechgroup, Inc..

What is the FDA product code for Macroduct Advanced Model 3710?

The FDA product code for Macroduct Advanced Model 3710 is KTB.

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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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