San Antonio Stopcock— 510(k) K181712

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K181712 for San Antonio Stopcock, Substantially Equivalent on 2018-07-26. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-28
Decision date: 2018-07-26
Decision: Substantially Equivalent
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.