Fusion Quattro Extraction Balloon— 510(k) K200247

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K200247 for Fusion Quattro Extraction Balloon, Substantially Equivalent on 2020-02-27. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code GCA
Advisory panel: Gastroenterology, Urology
Date received: 2020-01-31
Decision date: 2020-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Winston-Salem, NC, US

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