Name: Predicase
Price: 199 USD

K-number	K241836
Device name	Kem Medical Lead-free Chemical Indicators for Steam Sterilization
Applicant	Kem Medical Products Corporation
Product code	JOJ
Device class	Class II
Decision date	Sep 30, 2024
Decision	Substantially Equivalent
Regulation	880.2800

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Kem Medical Lead-free Chemical Indicators for Steam Sterilization

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