Name: Predicase
Price: 199 USD

K-number	DEN240075
Device name	Prolystica Pass Thru Disinfectant Wipes
Applicant	Steris
Product code	SHM
Device class	Class unclassified
Decision date	May 1, 2026
Decision	Not Substantially Equivalent
Regulation	—

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Prolystica Pass Thru Disinfectant Wipes

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