K-number	K133144
Device name	SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
Applicant	Crossbay Medical, Inc.
Product code	PGK
Device class	Class II
Decision date	Mar 19, 2014
Decision	Substantially Equivalent
Regulation	884.4530

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View the full FDA submission: accessdata.fda.gov

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SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE

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