The following data is part of a De Novo classification by Office Research In Clinical Amplifiction with the FDA for Widexlink In Clear Series Hearing Aids.
| DeNovo ID | DEN100025 |
| Device Name: | WIDEXLINK IN CLEAR SERIES HEARING AIDS |
| Classification | Hearing Aid, Air Conduction With Wireless Technology |
| Applicant | OFFICE RESEARCH IN CLINICAL AMPLIFICTION 2300 Cabot Drive suite 415 Lisle, IL 60532 |
| Contact | Francis Kuk |
| Product Code | OSM |
| CFR Regulation Number | 874.3305 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K101699 |
| Review Advisory Board | Ear Nose & Throat |
| Classification Advisory | Ear Nose & Throat |
| Type | Post-NSE |
| Date Received | 2010-10-13 |
| Decision Date | 2011-03-31 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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