K-number	K103215
Device name	CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
Applicant	Cianna Medical
Product code	JAQ
Device class	Class II
Decision date	Nov 15, 2010
Decision	Substantially Equivalent
Regulation	892.5700

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View the full FDA submission: accessdata.fda.gov

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CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

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