BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT— 510(k) K925173

Name: FDA 510(k) clearance K925173
Creator: U.S. Food and Drug Administration
Published: 1993-01-15

Substantially Equivalent

Westmed Intl.

FDA 510(k) clearance K925173 for BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT, Substantially Equivalent on 1993-01-15. Applicant: Westmed Intl.. Device class: 1.

Clearance details

Applicant: Westmed Intl.
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 1992-10-14
Decision date: 1993-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, 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.