| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2240713 | 2240713 | OTICON, INC. | 1 | Y | 2026-01-01 | 580 Howard Avenue SOMERSET NJ US 08873 |
| 3005465494 | 3005465494 | Oticon A/S | 1 | N | 2026-01-01 | Kongebakken 9 Smorum Hovedstaden DK DK-2765 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05707131339911 | Oticon - SIYA 1, KIT 10 75 C001 | +4539177100 | hama@oticon.com |
| 05707131339935 | Oticon - SIYA 1, KIT 10 75 PB C001 | +4539177100 | hama@oticon.com |
| 05707131339942 | Oticon - SIYA 1, KIT 10 85 C001 | +4539177100 | hama@oticon.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 8924 | 1841724562 | K133308 | TINNITUS SOUNDSUPPORT | KLW | 2014-03-18 |
| 180269 | 1841724562 | K133308 | TINNITUS SOUNDSUPPORT | KLW | 2014-03-18 |
| 8924 | 1055416567 | ||||
| 8924 | 1259664941 | ||||
| 180269 | 1055416567 | ||||
| 8924 | 1188283778 | ||||
| 180269 | 1188283778 | ||||
| 180269 | 1259664941 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KLW | 2 | 2014-03-18 |
Oticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS014 Date Received05/18/2022 Decision Date06/17/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Chan...
Oticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS012 Date Received04/29/2022 Decision Date05/27/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement ...
Oticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS011 Date Received02/23/2022 Decision Date03/15/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Chan...
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