CUSTOM IN-THE-EAR AND CANAL HEARING AID— 510(k) K862754
Substantially EquivalentCochlear Laboratories, Ltd.
FDA 510(k) clearance K862754 for CUSTOM IN-THE-EAR AND CANAL HEARING AID, Substantially Equivalent on 1986-08-01. Applicant: Cochlear Laboratories, Ltd.. Device class: 1.
Clearance details
- Applicant
- Cochlear Laboratories, 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
- Bloomington, MN, US
Recent devices under product code ESD
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