MODIFIED BIVONA EPISTAXIS CATHETER— 510(k) K900583

Name: FDA 510(k) clearance K900583
Creator: U.S. Food and Drug Administration
Published: 1990-08-09

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K900583 for MODIFIED BIVONA EPISTAXIS CATHETER, Substantially Equivalent on 1990-08-09. Applicant: Bivona Medical Technologies. Device class: 1.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1990-02-07
Decision date: 1990-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.