C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID— 510(k) K910314
Substantially EquivalentOtotech, Ltd.
FDA 510(k) clearance K910314 for C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID, Substantially Equivalent on 1991-03-18. Applicant: Ototech, Ltd.. Device class: 1.
Clearance details
- Applicant
- Ototech, Ltd.
- 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
- Minneapolis, MN, US
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