CONTINUOUS FLOW Y-TUBING— 510(k) K010122

Substantially Equivalent

G.U.-Tek

FDA 510(k) clearance K010122 for CONTINUOUS FLOW Y-TUBING, Substantially Equivalent on 2001-06-04. Applicant: G.U.-Tek. Device class: 2.

Clearance details

Applicant: G.U.-Tek
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2001-01-16
Decision date: 2001-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Plainfield, NJ, 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.