BIVONA NASAL TURBINATE STENT— 510(k) K935053

Name: FDA 510(k) clearance K935053
Creator: U.S. Food and Drug Administration
Published: 1994-07-01

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K935053 for BIVONA NASAL TURBINATE STENT, Substantially Equivalent on 1994-07-01. Applicant: Bivona Medical Technologies. Device class: 1.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 1993-10-21
Decision date: 1994-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

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K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE1993-10-06
K931749 — BIVONA(R) ICU ENDOTRACHEAL TUBE1993-08-10

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