Silk Voice— 510(k) K180631
Substantially EquivalentSofregen Medical, Inc.
FDA 510(k) clearance K180631 for Silk Voice, Substantially Equivalent on 2018-11-08. Applicant: Sofregen Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sofregen Medical, Inc.
- Product code
- Code MIX
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medford, MA, US
Recent devices under product code MIX
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