DUALYSE-CATH - CODES #1132.212, 1132.112— 510(k) K896568

Name: FDA 510(k) clearance K896568
Creator: U.S. Food and Drug Administration
Published: 1990-05-09

Substantially Equivalent

Vygon Corp.

FDA 510(k) clearance K896568 for DUALYSE-CATH - CODES #1132.212, 1132.112, Substantially Equivalent on 1990-05-09. Applicant: Vygon Corp.. Device class: 2.

Clearance details

Applicant: Vygon Corp.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-20
Decision date: 1990-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.