K-number	K142545
Device name	SonoFlow Sonohysterography and Sonohysterosalpingography Device
Applicant	Crossbay Medical, Inc.
Product code	LKF
Device class	Class II
Decision date	Mar 20, 2015
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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SonoFlow Sonohysterography and Sonohysterosalpingography Device

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