Name: Predicase
Price: 199 USD

K-number	K211286
Device name	Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Applicant	Pall Corporation
Product code	CAH
Device class	Class II
Decision date	Nov 16, 2021
Decision	Substantially Equivalent
Regulation	868.5260

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Source

View the full FDA submission: accessdata.fda.gov

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Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

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