K-number	K212717
Device name	Paneffort AAMI Level 3 Isolation Gown
Applicant	Paneffort, LLC
Product code	FYC
Device class	Class II
Decision date	Nov 30, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Paneffort AAMI Level 3 Isolation Gown

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