K-number	K173659
Device name	Howell D.A.S.H Extraction Balloon with Multiple Sizing
Applicant	Wilson-Cook Medical, Inc.
Product code	GCA
Device class	Class II
Decision date	Jul 6, 2018
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Howell D.A.S.H Extraction Balloon with Multiple Sizing

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