Name: Predicase
Price: 199 USD

K-number	K013276
Device name	ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
Applicant	Sewoon Medical Co., Ltd.
Product code	EZL
Device class	Class II
Decision date	Feb 15, 2002
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

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