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510(k) K151400

Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products by Jk Holding GmbH — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2015
Date Received
May 26, 2015
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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