GILTECH PLUS CONNECTING TUBE SET— 510(k) K983624

Name: FDA 510(k) clearance K983624
Creator: U.S. Food and Drug Administration
Published: 1999-03-18

Substantially Equivalent

Giltech Plus, Inc.

FDA 510(k) clearance K983624 for GILTECH PLUS CONNECTING TUBE SET, Substantially Equivalent on 1999-03-18. Applicant: Giltech Plus, Inc.. Device class: 2.

Clearance details

Applicant: Giltech Plus, Inc.
Product code: Code KDH
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-15
Decision date: 1999-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, PA, 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.