FDA 510(k) Applications for Medical Device:
Stopcock, I.V. Set
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K130245 | BAXTER HEALTHCARE CORP. |
32650 N WILSON RD. | ROUND LAKE | IL | 60073-0490 |
| K962581 | BAXTER HEALTHCARE CORP. |
RTE. 120 AND WILSON RD. | ROUND LAKE | IL | 60073 |
| K223175 | Baxter Healthcare Corporation |
25212 West Illinois Route 120 | Round Lake | IL | 60073 |
| K071400 | CARDINAL HEALTH, ALARIS PRODUCTS |
10221 WATERIDGE CIRCLE | SAN DIEGO | CA | 92121-2772 |
| K012157 | CHURCHILL MEDICAL SYSTEMS, INC. |
87 VENTURE DR. | DOVER | NH | 03820 |
| K954984 | DISTRONIC STERILE PRODUCTS, INC. |
124 HERITAGE AVE. | PORTSMOUTH | NH | 03801-5645 |
| K172266 | Dynarex Corporation |
10 Glenshaw Street | Orangeburg | NY | 10962 |
| K053405 | ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM | D.N. MEROM HAGALIL | 13860 | |
| K060231 | ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM | D.N. MEROM HAGALIL | 13860 | |
| K123084 | ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM | D.N. MEROM HAGALIL | 13860 | |
| K082106 | ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM | D.N. MEROM HAGALIL | 13860 | |
| K190489 | Elcam Medical ACAL |
Kibbutz Baram | Kibbutz Baram | 1386000 | |
| K141254 | ELCAM MEDICAL ACAL |
KIBBUTZ BARAM | MP MEROM HAGALIL | 1386000 | |
| K032393 | ELCAM MEDICAL ACAL |
7600 NORTH 15TH STREET | PHOENIX | AZ | 85020 |
| K211204 | Elcam Medical ACAL |
Kibbutz Baram | Kibbutz Baram | 1386000 | |
| K010217 | GEORGE LOO, MD |
9814 CURWOOD PLACE | BEVERLY HILLS | CA | 90210 |
| K061143 | HALKEY-ROBERTS CORP. |
11600 M.L. KING BLVD.,NORTH | ST. PETERSBURG | FL | 33716 |
| K080077 | ICU MEDICAL, INC |
4455 ATHERTON DR. | SALT LAKE CITY | UT | 84123 |
| K082836 | ICU MEDICAL, INC. |
4455 ATHERTON DRIVE | SALT LAKE CITY | UT | 84123 |
| K964435 | ICU MEDICAL, INC. |
951 CALLE AMANECER | SAN CLEMENTE | CA | 92673 |
| K982368 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K070143 | JMS NORTH AMERICA CORP. |
22320 FOOTHILL BLVD., | HAYWARD | CA | 94541 |
| K223499 | M/s Romsons International |
Unit-II, 9, Noida Special Economic Zone, Noida Dadri Road, | Noida | 201305 | |
| K052330 | MEDEGEN MEDICAL MANUFACTURING SERVICES |
930 WANAMAKER AVE. | ONTARIO | CA | 91761 |
| K242255 | Medex |
240 Allee Jacques Monod | Saint-Priest | 69800 | |
| K954970 | MEDEX, INC. |
6250 SHIER RINGS RD. | DUBLIN | OH | 40316 |
| K022895 | MEDICAL DEVICE CONSULTANTS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K955782 | MEDNET, INC. |
10572 MAHONEY DR. | SUNLAND | CA | 91040 |
| K190539 | MonuMedical, LLC |
3017 Douglas Blvd, Suite 300 | Roseville | CA | 95661 |
| K041779 | NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT | LEXINGTON | KY | 40514-1268 |
| K961982 | NORTH, INC. |
303 WASHINGTON, SUITE B | NORTHFIELD | MN | 55057 |
| K974083 | OHMEDA MEDICAL |
100 MOUNTAIN AVE. | MURRAY HILL | NJ | 07974-2005 |
| K082110 | SURGIN SURGICAL INSTRUMENTATION, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K210516 | Yomura Technologies Inc. |
No. 8, Gong 8th Rd., Linkou District | New Taipei City | 24450 |
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