K-number	K140321
Device name	INITARY BETTER BLADDER-PEDIATRIC
Applicant	Circulatory Technology, Inc.
Product code	DTN
Device class	Class II
Decision date	Apr 17, 2014
Decision	Substantially Equivalent
Regulation	870.4400

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Source

View the full FDA submission: accessdata.fda.gov

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INITARY BETTER BLADDER-PEDIATRIC

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