K-number	K200308
Device name	MTS Lefamulin 0.016- 256 µg/mL
Applicant	Liofilchem S. R. 1.
Product code	JWY
Device class	Class II
Decision date	Apr 6, 2020
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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MTS Lefamulin 0.016- 256 µg/mL

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