K-number	K201642
Device name	Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Applicant	Chalice Medical , Ltd.
Product code	DTZ
Device class	Class II
Decision date	Sep 18, 2020
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Paragon Adult Maxi PMP Oxygenator with Tubing Pack

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