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FDA 510(k)

3400E series; E5400 series; E6400 series; Sundazzler series

K-Number: K151905 · 2016-03-01

ApplicantHeartland Tanning, Inc.
Decision Date2016-03-01
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3400E series; E5400 series; E6400 series; Sundazzler series is a medical device manufactured by Heartland Tanning, Inc.. It received FDA 510(k) clearance on 2016-03-01 under approval number K151905. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3400E series; E5400 series; E6400 series; Sundazzler series?

3400E series; E5400 series; E6400 series; Sundazzler series is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by Heartland Tanning, Inc.. The 510(k) number is K151905.

When was 3400E series; E5400 series; E6400 series; Sundazzler series approved by the FDA?

3400E series; E5400 series; E6400 series; Sundazzler series received FDA 510(k) clearance on 2016-03-01, under approval number K151905.

What company makes 3400E series; E5400 series; E6400 series; Sundazzler series?

3400E series; E5400 series; E6400 series; Sundazzler series is manufactured by Heartland Tanning, Inc..

What is the FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series?

The FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series is LEJ.

Related Devices (Code: LEJ)

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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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