IN THE EAR HEARING AID— 510(k) K895368
Substantially EquivalentHearing Crafters of America
FDA 510(k) clearance K895368 for IN THE EAR HEARING AID, Substantially Equivalent on 1990-03-05. Applicant: Hearing Crafters of America. Device class: 1.
Clearance details
- Applicant
- Hearing Crafters of America
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mt. Vernon, MO, US
Recent devices under product code ESD
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