FDA 510(k) Applications for Medical Device:
Fab, Rhodamine, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013919 | BAYLIS MEDICAL CO., INC. |
5160 EXPLORER DRIVE, UNIT 33 | MISSISSAUGA, ONTARIO | L4W-4T7 | |
| K013304 | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. | SANDY | UT | 84070 |
| K022067 | BOSTON SCIENTIFIC |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K013866 | BOSTON SCIENTIFIC |
2710 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K013282 | W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. | FLAGSTAFF | AZ | 86002-0500 |
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