Name: Predicase
Price: 199 USD

K-number	K974475
Device name	THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
Applicant	Biocontrol Technology, Inc.
Product code	LJT
Device class	Class II
Decision date	Mar 2, 1998
Decision	Substantially Equivalent
Regulation	880.5965

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Source

View the full FDA submission: accessdata.fda.gov

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THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012

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