K-number	K143561
Device name	ELM PTA Balloon Dilatation Catheter
Applicant	O'Connell Regulatory Consultants, Inc.
Product code	LIT
Device class	Class II
Decision date	May 19, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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ELM PTA Balloon Dilatation Catheter

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