K-number	K231804
Device name	PRIME-XV FreezIS DMSO-Free MD
Applicant	Fujifilm Irvine Scientific
Product code	NDS
Device class	Class II
Decision date	Nov 9, 2023
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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PRIME-XV FreezIS DMSO-Free MD

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