Name: Predicase
Price: 199 USD

K-number	K100432
Device name	POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
Applicant	Medtronic Minimed
Product code	FPA
Device class	Class II
Decision date	Jul 9, 2010
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS

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