O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set— 510(k) K182066

Name: FDA 510(k) clearance K182066
Creator: U.S. Food and Drug Administration
Published: 2018-10-30

Unknown

Cook Incorporated

FDA 510(k) clearance K182066 for O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set, Unknown on 2018-10-30. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 2018-08-01
Decision date: 2018-10-30
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.