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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K182116 | Cochlear Americas |
13059 E. Peakview Ave. | Centennial | CO | 80111 |
| K150555 | COCHLEAR AMERICAS |
13059 E PEAKVIEW AVE | CENTENNIAL | CO | 80111 |
| K121317 | COCHLEAR AMERICAS |
13059 E PEAKVIEW AVE | CENTENNIAL | CO | 80111 |
| K080363 | COCHLEAR BONE ANCHORED SYSTEMS AB |
400 INVERNESS PARKWAY | ENGLEWOOD | CO | 80112 |
| K984162 | NOBELPHARMA USA, INC. |
777 OAKMONT LN. | WESTMONT | IL | 60559 |
| K112053 | OTICON MEDICAL AB |
EKONOMIVAGEN 2 | ASKIM | SE-436 33 | |
| K152067 | OTICON MEDICAL AB |
DATAVAGEN 37B | ASKIM | 436 32 | |
| K152820 | OTICON MEDICAL AB |
DATAVAGEN 37B | ASKIM | 436 32 | |
| K121228 | OTICON MEDICAL AB |
EKONOMIVAGEN 2 | ASKIM | SE-436 33 | |
| K203807 | Oticon Medical AB |
Datavagen 37B | Askim | SE-436 32 | |
| K142678 | OTICON MEDICAL AB |
EKONOMIVAGEN 2 | ASKIM | SE-436 33 |