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510(k) K151721

FIJI SUN FLUORESCENT TANNING UNIT by Kdb Inc. (Dba) Sperti Sunlamp — Product Code LEJ

K151721 is an FDA 510(k) premarket notification submitted by Kdb Inc. (Dba) Sperti Sunlamp for the device "FIJI SUN FLUORESCENT TANNING UNIT". 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
June 25, 2015
Clearance Type
Abbreviated
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