K-number	K123473
Device name	HOPER PTCA BALLOON CATHETER
Applicant	Lepu Medical Technology (Beijing) Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Aug 13, 2013
Decision	Substantially Equivalent
Regulation	870.5100

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View the full FDA submission: accessdata.fda.gov

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HOPER PTCA BALLOON CATHETER

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