Name: Predicase
Price: 199 USD

K-number	K180868
Device name	Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
Applicant	Cook Ireland
Product code	FGE
Device class	Class II
Decision date	Jul 6, 2018
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set

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