K-number	K172621
Device name	HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
Applicant	Hardy Diagnostics
Product code	JTN
Device class	Class II
Decision date	Oct 3, 2017
Decision	Substantially Equivalent
Regulation	866.1620

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View the full FDA submission: accessdata.fda.gov

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HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)

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