K-number	K192979
Device name	KLS Martin Individual Patient Solutions (IPS) Planning System
Applicant	KLS-Martin L.P.
Product code	PBF
Device class	Class II
Decision date	Mar 11, 2020
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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KLS Martin Individual Patient Solutions (IPS) Planning System

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