FDA 510(k) Applications for Medical Device:
Accessories, Blood Circuit, Hemodialysis
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K952572 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K071909 | BARKEY GMBH & CO. KG |
GEWERBESTRASSE 8 | LEOPOLDSHOEHE | D-33818 | |
| K955277 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K022536 | FRESENIUS MEDICAL CARE |
95 HAYDEN AVE. | LEXINGTON | MA | 02420 |
| K141997 | FRESENIUS MEDICAL CARE |
920 Winter Street | Waltham | MA | 02451 |
| K152953 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451-1457 |
| K010268 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K172238 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K201207 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K141281 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K160749 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
920 WINTER STREET | WALTHAM | MA | 02451 |
| K121599 | FRESENIUS MEDICAL CARE-NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451 |
| K081740 | INNOVATIONS FOR ACCESS, INC. |
515 NW SALTZMAN ROAD #797 | PORTLAND | OR | 97229-6098 |
| K983707 | JMS CO., LTD. |
12-17, KAKO-MACHI, NAKA-KU | HIROSHIMA | 730-8652 | |
| K002372 | MEDISYSTEMS CORP. |
1201 3RD AVE. | SEATTLE | WA | 98101-3016 |
| K971860 | MEDISYSTEMS CORP. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006 |
| K994306 | MEDISYSTEMS CORP. |
1201 3RD AVE. | SEATTLE | WA | 98101-3016 |
| K003712 | MOLDED PRODUCTS INC. |
P.O. BOX 15 | HARLAN | IA | 51537 |
| K082719 | NIKKISO CO. LTD. |
4-2-1 YUSHIMA | TOKYO | 113-0034 | |
| K230514 | Nikkiso Co., Ltd. |
20-3, Ebisu 4-Chome | Shibuya-ku | 150-6022 | |
| K231589 | Nikkiso Co., Ltd. |
20-3, Ebisu 4-Chome | Shibuya-Ku | 150-6022 | |
| K972206 | NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT | LEXINGTON | KY | 40514-1268 |
| K954676 | NISSHO CORP. |
7205 CORPORATE CENTER DR. | MIAMI | FL | 33126 |
| K081043 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K964041 | ROBERT R. STEVENS |
15720 BULL RUN RD. #377 | MIAMI LAKES | FL | 33014 |
| K020103 | STIHLER ELECTRONIC GMBH |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
| K082758 | STIHLER ELECTRONIC GMBH |
30 NORTHPORT RD. | SOUND BEACH | NY | 11789-1734 |
| K002816 | TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. | ITHACA | NY | 14850 |
| K030456 | VASC-ALERT L.L.C. |
1807 W. SUNNYSIDE AVE. | CHICAGO | IL | 60640 |
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