FDA 510(k) Applications for Medical Device:
Pump, Infusion, Enteral
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K111381 | ACACIA, INC. |
785 CHALLENGER STREET | BREA | CA | 92821 |
| K220230 | Amsino International Inc. |
708 Corporate Center Drive | Pomona | CA | 91768 |
| K200051 | Amsino International Inc. |
708 Corporate Center Drive | Pomona | CA | 91768 |
| K040957 | CAESAREA MEDICAL ELECTRONICS LTD. |
16 SHACHAM STREET | CAESAREA | 38900 | |
| K221603 | Cardinal Health LLC |
3651 Birchwood Drive | Waukegan | IL | 60085 |
| K143263 | COVIDIEN |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K153074 | COVIDIEN |
15 HAMPSHIRE STREET | MANSFILED | MA | 02048 |
| K141479 | COVIDIEN |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K011868 | DEBIOTECH S.A. |
16787 BERNARDO CENTER DR. | SAN DIEGO | CA | 92128-2504 |
| K011587 | ENTRACON CORP. |
22 WINDSOR DR. | FOXBOROUGH | MA | 02035 |
| K981541 | FRANTZ MEDICAL DEVELOPMENT, LTD. |
7740 METRIC DR. | MENTOR | OH | 44060 |
| K060316 | FRESENIUS KABI DEUTSCHLAND GMBH |
DAIMLERSTRASSE 22 | BAD HOMBURG | D-61352 | |
| K946168 | IVAC CORPORATION |
10300 CAMPUS POINT DR. | SAN DIEGO | CA | 92121 |
| K003047 | ROSS PRODUCT DIV. ABBOTT LABORATORIES |
625 CLEVELAND AVE. | COLUMBUS | OH | 43215-1724 |
| K031407 | ROSS PRODUCT DIV. ABBOTT LABORATORIES |
625 CLEVELAND AVE. | COLUMBUS | OH | 43215-1724 |
| K040196 | TYCO HEALTHCARE/KENDALL |
15 HAMPSHIRE STREET | MANSFIELD | MA | 02048 |
| K954735 | ZEVEX INTL., INC. |
P.O. BOX 414 | WEST JORDAN | UT | 80404-0414 |
| K031199 | ZEVEX INTL., INC. |
16787 BERNARDO CENTER DR. | SAN DIEGO | CA | 92128 |
| K131154 | ZEVEX, INC. |
4314 ZEVEX PARK LN. | SALT LAKE CITY | UT | 84123 |
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