SHARP II FULL CONTOUR— 510(k) K941292
Substantially EquivalentMiracle-Ear, Inc.
FDA 510(k) clearance K941292 for SHARP II FULL CONTOUR, Substantially Equivalent on 1994-05-12. Applicant: Miracle-Ear, Inc.. Device class: 1.
Clearance details
- Applicant
- Miracle-Ear, 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
- Golden Valley, MN, US
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