Name: Predicase
Price: 199 USD

K-number	K163442
Device name	Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
Applicant	Modern Medical Equipment Manufacturing Limited
Product code	GEI
Device class	Class II
Decision date	Sep 28, 2017
Decision	Substantially Equivalent
Regulation	—

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

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