PC COATED FLUOROPLASTIC VENT TUBES— 510(k) K000801

Name: FDA 510(k) clearance K000801
Creator: U.S. Food and Drug Administration
Published: 2000-06-19

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K000801 for PC COATED FLUOROPLASTIC VENT TUBES, Substantially Equivalent on 2000-06-19. Applicant: Gyrus Ent LLC. Device class: 2.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code ETD
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 2000-03-13
Decision date: 2000-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, 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.