3 Series Phototherapy Unit— 510(k) K153749

Name: FDA 510(k) clearance K153749
Creator: U.S. Food and Drug Administration
Published: 2016-06-30

Substantially Equivalent

Daavlin Distributing Company

FDA 510(k) clearance K153749 for 3 Series Phototherapy Unit, Substantially Equivalent on 2016-06-30. Applicant: Daavlin Distributing Company. Device class: 2.

Clearance details

Applicant: Daavlin Distributing Company
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2015-12-29
Decision date: 2016-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Bryan, OH, US

Download summary PDF View on FDA.gov ↗

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