K-number	K191809
Device name	MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
Applicant	Liofilchem s.r.l.
Product code	JWY
Device class	Class II
Decision date	Aug 23, 2019
Decision	Substantially Equivalent
Regulation	866.1640

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View the full FDA submission: accessdata.fda.gov

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MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

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