NORTHGATE FLOW ASSIST TUBING FOR UROLOGY— 510(k) K943361

Name: FDA 510(k) clearance K943361
Creator: U.S. Food and Drug Administration
Published: 1995-09-29

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K943361 for NORTHGATE FLOW ASSIST TUBING FOR UROLOGY, Substantially Equivalent on 1995-09-29. Applicant: Northgate Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Northgate Technologies, Inc.
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-13
Decision date: 1995-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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