FDA 510(k) Applications for Medical Device:
Catheter, Nephrostomy
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K121614 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K172929 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K063632 | C.R. BARD, INC. |
13183 HARLAND DRIVE | COVINGTON | GA | 30014-6421 |
| K080944 | C.R. BARD, INC. |
13183 HARLAND DRIVE | COVINGTON | GA | 30014-2655 |
| K051316 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K201165 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K211911 | Coloplast Corp |
1601 West River Road North | Minneapolis | MN | 55411 |
| K172527 | Cook Incorporated |
750 Daniels Way. P.O. Box 489 | Bloomington | IN | 47402 |
| K191498 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K183051 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K190903 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K183035 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K181735 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K171601 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K181713 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K961933 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K024050 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K132383 | GYRUS ACMI, INC. |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K160077 | JBW7 Innovations, LLC |
22200 W. 11 Mile Road, # 4182 | Southfield | MI | 48037 |
| K953713 | MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. | NORTHBROOK | IL | 60062 |
| K953601 | MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. | NORTHBROOK | IL | 60062 |
| K980193 | MEDICAL DEVICE TECHNOLOGIES, INC. |
4445 SW 35TH TERRACE | GAINESVILLE | FL | 32608 |
| K980192 | MEDICAL DEVICE TECHNOLOGIES, INC. |
4445 SW 35TH TERRACE | GAINESVILLE | FL | 32608 |
| K011121 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K980889 | URESIL CORP. |
5418 W. TOUHY AVE. | SKOKIE | IL | 60077 |
| K981344 | URESIL CORP. |
5418 W. TOUHY AVE. | SKOKIE | IL | 60077 |
| K222705 | YouCare Technology Co., Ltd. (Wuhan) |
Great Wall Science and Technology Park | Wuhan | ||
| K990689 | ZCV ,INC. |
298 FERNWOOD AVE. | EDISON | NJ | 08837 |
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