Name: Predicase
Price: 199 USD

K-number	K021216
Device name	SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
Applicant	Sterling Medivations, Inc.
Product code	FPA
Device class	Class II
Decision date	May 3, 2002
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS

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