SILASTIC VOICE PROSTHESIS— 510(k) K812864

Clearance details

Applicant

Dow Corning Corp. Healthcare Industries Materials

Product code

Code EWL

Device class

Class 2

Regulation

21 CFR 874.3730

Advisory panel

Ear, Nose, Throat

Date received

1981-10-13

Decision date

1981-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →