K-number	K172954
Device name	Medline Prevention CoolZone Gown
Applicant	Medline Industries, Inc.
Product code	FYA
Device class	Class II
Decision date	Jun 15, 2018
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Medline Prevention CoolZone Gown

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