FDA 510(k) Applications for Medical Device:
Pump, Infusion, Pca
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K022203 |
ABBOTT LABORATORIES |
DEPT 0389 BLDG J-45
| ABBOTT PARK |
IL |
60064-6133 |
| K032233 |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR.
| SAN DIEGO |
CA |
92121 |
| K043299 |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR.
| SAN DIEGO |
CA |
92121 |
| K990312 |
AMTEC MEDICAL |
9119 METRIC BLVD.
| AUSTIN |
TX |
78758 |
| K092313 |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD.
| ALLENTOWN |
PA |
18109-9341 |
| K002739 |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD.
| ROUND LAKE |
IL |
60073 |
| K051253 |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD
| MCGAW PARK |
IL |
60085 |
| K031566 |
BAXTER HEALTHCARE CORP. |
ONE BAXTER PKWY.
| DEERFIELD |
IL |
60015 |
| K013822 |
CANE SRL |
P.O. BOX 7007
| DEERFIELD |
IL |
60015 |
| K033054 |
HARVARD CLINICAL TECHNOLOGY |
22 PLEASANT ST.
| SOUTH NATICK |
MA |
01760 |
| K020421 |
HENNIG ENTERPRISES EUROPE S.R.L. |
25 SHANN ST., FLOREAT
| PERTH |
|
6014 |
| K143612 |
Hospira, Inc |
275 North Field Drive
| Lake Forest |
IL |
60045 |
| K043256 |
HOSPIRA, INC. |
275 N. FIELD DR., BLDG. H-2
| LAKE FOREST |
IL |
60045-5045 |
| K042800 |
HOSPIRA, INC. |
275 N. FIELD DR., BLDG. H-2
| LAKE FOREST |
IL |
60045-5045 |
| K020418 |
P.T. GREENLEAF |
25 SHANN ST., FLOREAT
| PERTH, WESTERN AUSTRALIA |
|
6014 |
| K982839 |
SIMS DELTEC, INC. |
1265 GREY FOX RD.
| ST. PAUL |
MN |
55112 |
| K170982 |
Smiths Medical ADS, Inc. |
6000 Nathan Lane North
| Minneapolis |
MN |
55442 |
| K130394 |
SMITHS MEDICAL ASD, INC. |
1265 GREY FOX ROAD
| ST. PAUL |
MN |
55112 |
| K072144 |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD.
| ARDEN HILLS |
MN |
55112 |
| K002434 |
SORENSON MEDICAL, INC. |
1375 WEST 8040 SOUTH
| WEST JORDAN |
UT |
84088-8320 |
| K030661 |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE.
| KALAMAZOO |
MI |
49001 |
| K162165 |
SUMMIT MEDICAL PRODUCTS, INC |
504 West 8360 South
| Sandy |
UT |
84070 |
|
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