EPISTAXIS CATHETER/KIT— 510(k) K821584

Name: FDA 510(k) clearance K821584
Creator: U.S. Food and Drug Administration
Published: 1982-06-14

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K821584 for EPISTAXIS CATHETER/KIT, Substantially Equivalent on 1982-06-14. 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: 1982-06-01
Decision date: 1982-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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