TULA Iontophoresis System with Earset— 510(k) K150453

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K150453 for TULA Iontophoresis System with Earset, Substantially Equivalent on 2015-05-20. Applicant: Acclarent, Inc..

Clearance details

Applicant: Acclarent, Inc.
Product code: Code EGJ
Advisory panel: Physical Medicine
Date received: 2015-02-20
Decision date: 2015-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Rmenlo Park, CA, US

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