K-number	K221903
Device name	Delta III Pro
Applicant	Dornier Medtech America, Inc.
Product code	LNS
Device class	Class II
Decision date	Feb 22, 2023
Decision	Substantially Equivalent
Regulation	876.5990

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Source

View the full FDA submission: accessdata.fda.gov

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Delta III Pro

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