CATHETER WITHDRAWAL UNIT— 510(k) K881878

Name: FDA 510(k) clearance K881878
Creator: U.S. Food and Drug Administration
Published: 1988-07-28

Substantially Equivalent

Eris Medical Technology

FDA 510(k) clearance K881878 for CATHETER WITHDRAWAL UNIT, Substantially Equivalent on 1988-07-28. Applicant: Eris Medical Technology. Device class: 2.

Clearance details

Applicant: Eris Medical Technology
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1988-05-04
Decision date: 1988-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Providence, 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.