Silk Voice (SMI-04)— 510(k) K240919

Substantially Equivalent

Sofregen Medical

FDA 510(k) clearance K240919 for Silk Voice (SMI-04), Substantially Equivalent on 2024-05-03. Applicant: Sofregen Medical.

Clearance details

Applicant: Sofregen Medical
Product code: Code MIX
Advisory panel: Ear, Nose, Throat
Date received: 2024-04-03
Decision date: 2024-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Framingham, MA, US

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