Name: Predicase
Price: 199 USD

K-number	K240330
Device name	HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
Applicant	O&M Halyard, Inc.
Product code	FRG
Device class	Class II
Decision date	Aug 7, 2024
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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

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