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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 |
|---|---|---|---|---|---|
| K240164 | Bain Medical Equipment (Guangzhou) Co., Ltd. |
No.10 Juncheng Road, No.10, Juncheng Road Eastern Area | Guangzhou | 510760 | |
| K964337 | CIRCULATORY TECHNOLOGY, INC. |
21 SINGWORTH ST. | OYSTER BAY | NY | 11771 |
| K000702 | FRESENIUS MEDICAL CARE NORTH AMERICA |
TWO LEDGEMONT CENTER | LEXINGTON | MA | 02420 |
| K003445 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K970536 | MEDISYSTEMS CORP. |
1201 3RD AVE. | SEATTLE | WA | 98101-3016 |
| K983076 | MEDISYSTEMS CORP. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006 |
| K001465 | NIPRO MEDICAL CORP. |
510 STONEMONT DR. | WESTON | FL | 33326 |
| K010264 | NIPRO MEDICAL CORP. |
510 STONEMONT DR. | WESTON | FL | 33326 |
| K072988 | NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. | MIAMI | FL | 33172 |
| K001971 | OFI BIOMEDICA S.P.A. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |