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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 |
|---|---|---|---|---|---|
| K992847 | ELAN HOLDINGS, INC. |
231 NORTH PUENTE ST. | BREA | CA | 92821 |
| K990039 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K963537 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |