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510(k) K180581

UV Lamps for Sunlamp Products by Feilo Sylvania Germany GmbH — Product Code LEJ

K180581 is an FDA 510(k) premarket notification submitted by Feilo Sylvania Germany GmbH for the device "UV Lamps for Sunlamp Products". The FDA issued a decision of Substantially Equivalent on June 22, 2018. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2018
Date Received
March 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Booth, Sun Tan
Device Class
Class II
Regulation Number
878.4635
Review Panel
SU
Submission Type

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FDA data resources