K-number	K190813
Device name	CrossBay Cervical Dilator Catheter System
Applicant	Crossbay Medical
Product code	PON
Device class	Class II
Decision date	Aug 23, 2019
Decision	Substantially Equivalent
Regulation	884.4260

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Source

View the full FDA submission: accessdata.fda.gov

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CrossBay Cervical Dilator Catheter System

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