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510(k) Data Aggregation

K Number

Device Name

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

Manufacturer

HEARTLAND TANNING, INC.

Date Cleared

2016-03-01

(232 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

HEARTLAND TANNING, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

This sunlamp product is intended exclusively for cosmetic tanning of the human skin.

Device Description

Not Found

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