PRECEPTIS TYMPANOSTOMY TUBE INSERTER— 510(k) K133921

Name: FDA 510(k) clearance K133921
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Substantially Equivalent

Preceptis Medical

FDA 510(k) clearance K133921 for PRECEPTIS TYMPANOSTOMY TUBE INSERTER, Substantially Equivalent on 2014-08-22. Applicant: Preceptis Medical. Device class: 2.

Clearance details

Applicant: Preceptis Medical
Product code: Code ETD
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 2013-12-23
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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