K-number	K003320
Device name	PTA-OS SIZING BALLOON, MODEL 360
Applicant	NuMED, Inc.
Product code	MJN
Device class	Class II
Decision date	May 2, 2001
Decision	Substantially Equivalent
Regulation	870.4450

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View the full FDA submission: accessdata.fda.gov

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PTA-OS SIZING BALLOON, MODEL 360

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