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510(k) K180555

Ergoline Prestige 1600 Hybrid Performance by Jk Holding GmbH — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 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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