FDA 510(k) Applications for Medical Device:
Dialyzer Reprocessing System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013713 | ALCAVIS INTERNATIONAL INCORPORATED |
8-8 METROPOLITAN CT. | GAITHERSBURG | MD | 20878 |
| K043126 | ALCAVIS INTERNATIONAL, INC. |
8-8 METROPOLITAN CT. | GAITHERSBURG | MD | 20878 |
| K970799 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K992016 | AMUCHINA INTL., INC. |
8-8 METROPOLITAN CT. | GAITHERSBURG | MD | 20878 |
| K974798 | ENVIRONMENTAL TEST SYSTEMS, INC. |
23575 COUNTY RD., #106 | ELKHART | IN | 46514 |
| K040660 | HACH COMPANY |
23575 COUNTY ROAD 106 | ELKHART | IN | 46514 |
| K024076 | HDC MAQUINOLAS, LLC |
8508 BEACON BEND LN. | PEARLAND | TX | 77584 |
| K033505 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K991851 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K941757 | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
RESERVOIR PLACE | WALTHAM | MA | 02154 |
| K091360 | NOVAFLUX TECHNOLOGIES |
1 WALL STREET | PRINCETON | NJ | 08540 |
| K941867 | RENAL SCIENTIFIC SERVICE, INC. |
RESERVIOR PLACE | WALTHAM | MA | 02145 |
| K974426 | REPROCESSING PRODUCTS CORP. |
8662 COMSTOCK LN. | MAPLE GROVE | MN | 55311 |
| K955299 | SERATRONICS, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K931336 | SERATRONICS, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
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