Name: Predicase
Price: 199 USD

K-number	K210873
Device name	Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
Applicant	Oxoid Limited (Part of Thermo Fisher Scientific)
Product code	JTN
Device class	Class II
Decision date	Oct 27, 2021
Decision	Substantially Equivalent
Regulation	866.1620

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Source

View the full FDA submission: accessdata.fda.gov

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Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

Everything you need for a 510(k) submission. Nothing you don't.