FDA 510(k) Applications for Medical Device:
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K952631 | B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. | BETHLEHEM | PA | 18018 |
| K161582 | Bain Medical Equipment (Guangzhou) Co., Ltd |
No. 10 Juncheng Road | Guangzhou | 510760 | |
| K201866 | Bain Medical Equipment(Guangzhou) Co., Ltd. |
No.10, Juncheng Road, Eastern Area, | Guangzhou | 510760 | |
| K013634 | BIOTEQUE CORP. |
3892 SOUTH AMERICA WEST TRAIL | FLAGGSTAFF | AZ | 86001 |
| K992930 | BIOTEQUE CORP. |
900 N. SWITZER CANYON DR. #142 | FLAGSTAFF | AZ | 86001 |
| K171952 | Dimesol, Inc. |
509 Fishing Creek Road | Lewisberry | PA | 17339 |
| K063293 | EDWARDS LIFESCIENCES SERVICES GMBH |
BUSINESS & TECHNOLOGY CENTER | STEVENAGE, HERTSFORDSHIRE | SG1 2DX | |
| K992039 | EXELINT INTL. CO. |
5840 WEST CENTINELA AVE. | LOS ANGELES | CA | 90045 |
| K012242 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K001107 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02173 |
| K000451 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02173 |
| K001873 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02173 |
| K120823 | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
920 Winter Street | Waltham | MA | 02451-1457 |
| K213992 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K070414 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K063290 | GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K100364 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K982340 | HAIDYLENA MEDICAL EGYPT |
26, MAKRAM EBEID ST. | NASR CITY, CAIRO | 11371 | |
| K140841 | HOME DIALYSIS PLUS |
257 HUMBOLDT COURT | SUNNYVALE | CA | 94089 |
| K983559 | ICU MEDICAL, INC. |
951 CALLE AMANECER | SAN CLEMENTE | CA | 92673 |
| K202796 | Jiangxi Sanxin Medtec Co., Ltd. |
No. 999, Fushan Road, Xiaolan Economic Development | Nanchang | 330200 | |
| K032975 | JMS NORTH AMERICA CORP. |
22320 FOOTHILL BLVD., | HAYWARD | CA | 94541 |
| K953823 | MEDISYSTEMS CORP. |
1575 EYE ST., N.W. | WASHINGTON | DC | 20005 |
| K971687 | NATIONAL MEDICAL CARE, INC. |
2 VOLVO DR. | ROCKLEIGH | NJ | 07647 |
| K971313 | NATIONAL MEDICAL CARE, INC. |
2 VOLVO DR. | ROCKLEIGH | NJ | 07647 |
| K962081 | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
2 VOLVO DR. | ROCKLEIGH | NJ | 07647 |
| K072024 | NIPRO MEDICAL CORP. |
3150 NW 107 AVE.. | MIAMI | FL | 33172 |
| K112628 | NIPRO MEDICAL CORPORATION |
3150 N.W. 107TH AVE. | MIAMI | FL | 33172 |
| K080807 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K090255 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K210782 | Outset Medical, Inc. |
3052 Orchard Drive | San Jose | CA | 95134 |
| K150304 | Oxyless Ltd |
Third Floor, Bewlay House, 2 Swallow Place | London | ||
| K014140 | SUNDER BIOMEDICAL TECH. CO., LTD. |
10F-1, 1-67, WU-CHUAN RD. | TAICHUNG CITY | 403 |
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