Name: Predicase
Price: 199 USD

K-number	K150679
Device name	EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
Applicant	Boston Scientific Corp
Product code	PIF
Device class	Class II
Decision date	May 29, 2015
Decision	Substantially Equivalent — Kit Device
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector

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