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510(k) K181455

ProSun sunlamp products, Luxura sunlamp products by Prosun International, LLC — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2018
Date Received
June 4, 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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