K-number	K121175
Device name	FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
Applicant	Ostial Corporation
Product code	LIT
Device class	Class II
Decision date	Jun 29, 2012
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM

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