K-number	K191866
Device name	GelPOINT Mini Advanced Access Platform
Applicant	Applied Medical
Product code	GCJ
Device class	Class II
Decision date	Apr 29, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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GelPOINT Mini Advanced Access Platform

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