Name: Predicase
Price: 199 USD

K-number	K210310
Device name	CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
Applicant	Nuance Medical, LLC
Product code	GEH
Device class	Class II
Decision date	Oct 22, 2021
Decision	Substantially Equivalent
Regulation	878.4350

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit

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