Name: Predicase
Price: 199 USD

K-number	K193522
Device name	iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
Applicant	Kitazato Corporation
Product code	MQL
Device class	Class II
Decision date	Aug 25, 2020
Decision	Substantially Equivalent
Regulation	884.6180

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

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