Cytosponge Cell Collection Device— 510(k) K152794

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K152794 for Cytosponge Cell Collection Device, Substantially Equivalent on 2016-04-12. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code EOX
Advisory panel: Ear, Nose, Throat
Date received: 2015-09-28
Decision date: 2016-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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