One-Step Suprapubic Introducer— 510(k) K182709

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K182709 for One-Step Suprapubic Introducer, Substantially Equivalent on 2018-12-26. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code KOB
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-27
Decision date: 2018-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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