HEARING AID, UNITRON MODEL UI5— 510(k) K882375
Substantially EquivalentUnitron Industries, Inc.
FDA 510(k) clearance K882375 for HEARING AID, UNITRON MODEL UI5, Substantially Equivalent on 1988-08-09. Applicant: Unitron Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Unitron Industries, Inc.
- 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
- Port Huron, MI, US
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