MICRODOSE CATH, MODELS 90121-201, -202, -203— 510(k) K011383

Name: FDA 510(k) clearance K011383
Creator: U.S. Food and Drug Administration
Published: 2001-06-25

Substantially Equivalent

Durect Corp.

FDA 510(k) clearance K011383 for MICRODOSE CATH, MODELS 90121-201, -202, -203, Substantially Equivalent on 2001-06-25. Applicant: Durect Corp.. Device class: 2.

Clearance details

Applicant: Durect Corp.
Product code: Code ETD
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 2001-05-07
Decision date: 2001-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Cupertino, CA, 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.