INTRA-ORAL ARTIFICIAL LARYNX— 510(k) K831127
Substantially EquivalentXomed, Inc.
FDA 510(k) clearance K831127 for INTRA-ORAL ARTIFICIAL LARYNX, Substantially Equivalent on 1983-07-28. Applicant: Xomed, Inc.. Device class: 1.
Clearance details
- Applicant
- Xomed, Inc.
- Product code
- Code ESE
- Device class
- Class 1
- Regulation
- 21 CFR 874.3375
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arnold, MO, US
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