K-number	K181959
Device name	HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
Applicant	Owens & Minor Halyard, Inc.
Product code	FRG
Device class	Class II
Decision date	Mar 22, 2019
Decision	Substantially Equivalent
Regulation	880.6850

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View the full FDA submission: accessdata.fda.gov

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HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

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