K-number	K160049
Device name	Charisma
Applicant	Heraeus Kulzer, LLC (Mitsui Chemicals Group)
Product code	EBF
Device class	Class II
Decision date	Nov 15, 2016
Decision	Substantially Equivalent
Regulation	872.3690

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View the full FDA submission: accessdata.fda.gov

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Charisma

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