Serenity— 510(k) K150014

Substantially Equivalent

Sanuthera, Inc.

FDA 510(k) clearance K150014 for Serenity, Substantially Equivalent on 2015-07-27. Applicant: Sanuthera, Inc..

Clearance details

Applicant: Sanuthera, Inc.
Product code: Code KLW
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-05
Decision date: 2015-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

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