Silk Voice— 510(k) K180631

Substantially Equivalent

Sofregen Medical, Inc.

FDA 510(k) clearance K180631 for Silk Voice, Substantially Equivalent on 2018-11-08. Applicant: Sofregen Medical, Inc..

Clearance details

Applicant: Sofregen Medical, Inc.
Product code: Code MIX
Advisory panel: Ear, Nose, Throat
Date received: 2018-03-09
Decision date: 2018-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, MA, US

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