K-number	K182922
Device name	MTS Omadacycline 0.002-32 µg/mL
Applicant	Liofilchem s.r.l.
Product code	JWY
Device class	Class II
Decision date	Dec 14, 2018
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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MTS Omadacycline 0.002-32 µg/mL

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