OTOMEDICS SOFT TYMPANOSTOMY TUBE— 510(k) K071178

Name: FDA 510(k) clearance K071178
Creator: U.S. Food and Drug Administration
Published: 2007-06-22

Substantially Equivalent

Otomedics Advanced Medical Technologies, Ltd.

FDA 510(k) clearance K071178 for OTOMEDICS SOFT TYMPANOSTOMY TUBE, Substantially Equivalent on 2007-06-22. Applicant: Otomedics Advanced Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Otomedics Advanced Medical Technologies, Ltd.
Product code: Code ETD
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 2007-04-27
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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