DENRICK SPEECH AID (DR-1)— 510(k) K931371
Substantially EquivalentDenrick Corp.
FDA 510(k) clearance K931371 for DENRICK SPEECH AID (DR-1), Substantially Equivalent on 1993-08-25. Applicant: Denrick Corp.. Device class: 1.
Clearance details
- Applicant
- Denrick Corp.
- 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
- Honolulu, HI, US
Recent devices under product code ESE
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