FDA 510(k) Applications for Medical Device:
Catheter, Urethral
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961361 | A+ PRODUCTS |
16 ALDEN PL. | WEST NEWTON | MA | 02465 |
| K011552 | APOGEE MEDICAL, INC. |
90 WEATHERS ST. | YOUNGSVILLE | NC | 27549 |
| K992137 | APOGEE, INC. |
7517-101 PRECISION DR. | RALEIGH | NC | 27613 |
| K050874 | ASTRA TECH, INC. |
20 MAIN STREET | NORTHBOROUGH | MA | 01532 |
| K043241 | ASTRA TECH, INC. |
20 MAIN STREET | NORTHBOROUGH | MA | 01532 |
| K012374 | ASTRA TECH, INC. |
96 WEST MAIN ST. | NORTHBOROUGH | MA | 01532 |
| K180801 | B. Braun Medical Inc. |
901 Marcon Boulevard | Allentown | PA | 18109 |
| K192577 | B. Braun Medical Inc. |
901 Marcon Boulevard | Allentown | PA | 18109 |
| K151772 | B. BRAUN MEDICAL INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109 |
| K965067 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K060268 | CLAY KENNARD |
2909 BROWNE STONE ROAD | OKLAHOMA CITY | OK | 73120 |
| K192904 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K200820 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K180070 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K190620 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K200142 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K180258 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K150935 | COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH | MINNEAPOLIS | MN | 55411 |
| K143182 | COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH | MINNEAPOLIS | MN | 55411 |
| K121458 | COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH | MINNEAPOLIS | MN | 55411 |
| K023254 | COLOPLAST CORP. |
1940 COMMERCE DR. | NORTH MANKATO | MN | 56003 |
| K072808 | COLOPLAST CORP. |
1601 WEST RIVER N | MINNEAPOLIS | MN | 55411 |
| K121457 | COLOPLAST CORP. |
1601 WEST RIVER RD NORTH | MINNEAPOLIS | MN | 55411 |
| K161672 | Coloplast Corp. |
1601 West River Road North | Minneapolis | MN | 55411 |
| K213283 | ConvaTec Limited |
GDC, First Avenue, Deeside industrial Park | Deeside | CH5 2NU | |
| K181206 | ConvaTec Limited |
GDC, First Avenue, Deepside Industrial Park | Deeside | CH5 2NU | |
| K172278 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K182511 | F&S Medical Solutions, LLC |
10221 Woodridge Lane | Omaha | NE | 68124 |
| K101900 | HAKKI MEDICAL TECHNOLOGIES, INC. |
3851 62ND AVE. NORTH | PINELLAS PARK | FL | 33781 |
| K191512 | Hakki Medical Technologies, Inc. |
10333 Seminole Boulevard, Suite #8 | Largo | FL | 33778 |
| K111405 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
NO. 8-1, LONGQUAN ROAD | HANGZHOU, ZHEJIANG | 311121 | |
| K192468 | Hangzhou Bever Medical Devices Co., Ltd. |
Building 2, No. 1-1, Houmuqiao, Yongle Village, | Hangzhou | 311121 | |
| K200134 | Hangzhou Jimushi Meditech Co., Ltd. |
5F, Building 2, No. 12 Longtan Road, Cangqian Street, | Hangzhou | ||
| K191633 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K211436 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K163179 | HOLLISTER INCORPORATED |
2000 HOLLISTER DRIVE | LIBERTYVILLE | IL | 60048 |
| K183253 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K180824 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K152268 | HOLLISTER INCORPORATED |
2000 HOLLISTER DR | LIBERTYVILLE | IL | 60048 |
| K193148 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K143594 | Hollister Incorporated |
2000 Hollister Drive | Libertyville | IL | 60048 |
| K090960 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K141642 | HOLLISTER, INCORPORATED |
2000 HOLLISTER DRIVE | LIBERTYVILLE | IL | 60048 |
| K110862 | HOLLISTER, INCORPORATED |
2000 HOLLISTER DRIVE | ;IBERTYVILLE | IL | 60048 |
| K063795 | MARIAN MEDICAL, INC. |
319 WESTPORT DR. | LOUISVILLE | KY | 40207 |
| K973120 | MEDICAL TECHNOLOGIES OF GEORGIA |
5335-A DIVIDEND DR. | DECATUR | GA | 30035 |
| K031409 | PROMEDIC, INC. |
6329 WEST WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K160795 | ROBLING MEDICAL |
90 WEATHERS STREET | YOUNGSVILLE | NC | 27596 |
| K970704 | ROCHESTER MEDICAL CORP. |
1500 NW 2ND AVE. | STEWARTVILLE | MN | 55976 |
| K020714 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K993651 | SC HENNIG ENTERPRISES EUROPE SRL |
25 SHANN ST. | WESTERN AUSTRALIA | 6014 | |
| K183461 | Teleflex Medical, Inc |
3015 Carrington Mill Blvd , Suite 600 North | Morrisville | NC | 27560 |
| K142767 | ThinkMed Medical Technology Co., Ltd. |
No.4 Building, 322 Hongyang Road, Qiandeng Town | Kunshan | 215341 | |
| K021938 | VITALCARE, INC. |
15800 NW 13TH AVE. | MIAMI | FL | 33169 |
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