K-number	K182895
Device name	Wilson-Cook Achalasia Balloon
Applicant	Wilson-Cook Medical, Inc.
Product code	PID
Device class	Class II
Decision date	Jan 25, 2019
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Wilson-Cook Achalasia Balloon

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