K-number	K203661
Device name	CRYO Arctic, CRYO Penguin
Applicant	Cryoscience North America, Inc.
Product code	MLY
Device class	Class U
Decision date	May 25, 2022
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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CRYO Arctic, CRYO Penguin

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