K-number	K180555
Device name	Ergoline Prestige 1600 Hybrid Performance
Applicant	Jk Holding GmbH
Product code	LEJ
Device class	Class II
Decision date	Oct 11, 2018
Decision	Substantially Equivalent
Regulation	878.4635

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Source

View the full FDA submission: accessdata.fda.gov

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Ergoline Prestige 1600 Hybrid Performance

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