ORISE Gel— 510(k) K180068

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K180068 for ORISE Gel, Substantially Equivalent on 2018-09-28. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code PLL
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-09
Decision date: 2018-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

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