3400E series; E5400 series; E6400 series; Sundazzler series— 510(k) K151905

Name: FDA 510(k) clearance K151905
Creator: U.S. Food and Drug Administration
Published: 2016-03-01

Substantially Equivalent

Heartland Tanning, Inc.

FDA 510(k) clearance K151905 for 3400E series; E5400 series; E6400 series; Sundazzler series, Substantially Equivalent on 2016-03-01. Applicant: Heartland Tanning, Inc.. Device class: 2.

Clearance details

Applicant: Heartland Tanning, Inc.
Product code: Code LEJ
Device class: Class 2
Regulation: 21 CFR 878.4635
Advisory panel: General, Plastic Surgery
Date received: 2015-07-13
Decision date: 2016-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lees Summit, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.