ChitoZolve— 510(k) K181696

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K181696 for ChitoZolve, Substantially Equivalent on 2018-11-30. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code LYA
Advisory panel: Ear, Nose, Throat
Date received: 2018-06-27
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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