Name: Predicase
Price: 199 USD

K-number	K180574
Device name	Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
Applicant	J & J Solutions, Inc. D/B/A/ Corvida Medical
Product code	ONB
Device class	Class II
Decision date	Aug 17, 2018
Decision	Substantially Equivalent
Regulation	880.5440

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor

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