K-number	K131869
Device name	PTS-X SIZING BALLOON CATHETER
Applicant	NuMED, Inc.
Product code	MJN
Device class	Class II
Decision date	Aug 8, 2013
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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PTS-X SIZING BALLOON CATHETER

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