Name: Predicase
Price: 199 USD

K-number	K033333
Device name	SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
Applicant	Aomori Olympus Co., Ltd.
Product code	FGE
Device class	Class II
Decision date	Nov 14, 2003
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B

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