Instrument Case— 510(k) K231604

Substantially Equivalent

Cochlear Americas

FDA 510(k) clearance K231604 for Instrument Case, Substantially Equivalent on 2023-08-24. Applicant: Cochlear Americas.

Clearance details

Applicant: Cochlear Americas
Product code: Code KCT
Advisory panel: General Hospital
Date received: 2023-06-01
Decision date: 2023-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Lone Tree, CO, US

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