Name: Predicase
Price: 199 USD

K-number	K222440
Device name	Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
Applicant	Steris
Product code	FRG
Device class	Class II
Decision date	Sep 9, 2022
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

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