K-number	K212464
Device name	Dukal Corporation AAMI Level 4 Open-Back Protective Gown
Applicant	Dukal Corporation
Product code	QPC
Device class	Class II
Decision date	Mar 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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Dukal Corporation AAMI Level 4 Open-Back Protective Gown

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