K-number	K112856
Device name	LUCINA-MELODI
Applicant	Genadyne Biotechnologies, Inc.
Product code	HGX
Device class	Class II
Decision date	May 10, 2012
Decision	Substantially Equivalent
Regulation	884.5160

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View the full FDA submission: accessdata.fda.gov

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LUCINA-MELODI

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