Name: Predicase
Price: 199 USD

K-number	K153006
Device name	Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
Applicant	Sterilmed, Inc.
Product code	NLH
Device class	Class II
Decision date	Jun 23, 2016
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter

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