BURGET NASAL STENT— 510(k) K942025

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K942025 for BURGET NASAL STENT, Substantially Equivalent on 1995-10-27. Applicant: Bivona Medical Technologies. Device class: 1.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code LWF
Device class: Class 1
Regulation: 21 CFR 874.3900
Advisory panel: Ear, Nose, Throat
Date received: 1994-04-26
Decision date: 1995-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LWF

K181219 — OptiPillows EPAP Mask2018-08-03
K120665 — INVENT SNORING DEVICE2012-06-12
K040491 — CHIN-UP STRIP2004-09-10
K982929 — MAXAIR NASAL DILATOR SYSTEM1998-09-09
K963326 — BREATHE FIT1997-02-12

More clearances from Bivona Medical Technologies

K952700 — SUPERSLICK1995-10-31
K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES1994-10-27
K935053 — BIVONA NASAL TURBINATE STENT1994-07-01
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.