Name: Predicase
Price: 199 USD

K-number	K122587
Device name	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
Applicant	St Jude Medical
Product code	DRC
Device class	Class II
Decision date	Feb 7, 2013
Decision	Substantially Equivalent
Regulation	870.1390

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Source

View the full FDA submission: accessdata.fda.gov

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BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

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