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FDA 510(k) Applications Submitted by Jaak Janssens
FDA 510(k) Number
Submission Date
Device Name
Applicant
K080095
01/14/2008
CORAMATE/SPIROTOME SYSTEM
MEDINVENTS
K190378
02/19/2019
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
Bioncise NV
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