K-number	K183045
Device name	Eclipse 2L
Applicant	Balt USA, LLC
Product code	MJN
Device class	Class II
Decision date	Apr 30, 2019
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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Eclipse 2L

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