FDA 510(k) Applications for Medical Device:
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K082831 | AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K030664 | AMSINO INTERNATIONAL, INC. |
4501 BRICKELL PRIVADO ST. | ONTARIO | CA | 91761 |
| K030712 | AMSINO INTERNATIONAL, INC. |
4501 BRICKELL PRIVADO ST. | ONTARIO | CA | 91761 |
| K223821 | Coloplast |
1601 West River Road North | Minneapolis | MN | 55411 |
| K070939 | COLOPLAST MANUFACTURING US, LLC |
1601 WEST RIVER ROAD | MINNEAPOLIS | MN | 55411 |
| K962073 | CONTINENTAL MEDICAL LABORATORIES, INC. |
817 W.MOHR AVE. | WATERFORD | WI | 53185 |
| K960214 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K960215 | CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 | ORLANDO | FL | 32811 |
| K961442 | CUSTOMED, INC. |
CALLE IGUALDAD #7 | FAJARDO | PR | 00738 |
| K002803 | GO MEDICAL INDUSTRIES PTY. LTD. |
200 CHURCHILL AVE. | SUBIACO, PERTH | 6008 | |
| K011055 | GO MEDICAL INDUSTRIES PTY. LTD. |
200 CHURCHILL AVE. | SUBIACO, PERTH | 6008 | |
| K070048 | MARIAN MEDICAL, INC. |
319 WESTPORT DR. | LOUISVILLE | KY | 40207 |
| K003873 | MENTOR CORP. |
201 MENTOR DR. | SANTA BARBARA | CA | 93111 |
| K960566 | NATIONAL HEALTHCARE MFG. CORP. |
251 SAULTEAUX CRESCENT | WINNIPEG, MANITOBA | R3J 3C7 | |
| K962254 | NATIONAL HEALTHCARE MFG. CORP. |
251 SAULTEAUX CRESCENT | WINNIPEG, MANITOBA | R3J 3C7 | |
| K983010 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K010420 | RUSCH, INC. |
2450 MEADOWBROOK PKWY. | DULUTH | GA | 30096 |
| K963993 | RUSCH, INC. |
TALL PINES PARK | JAFFREY | NH | 03452 |
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