FDA 510(k) Applications for Medical Device:
Collector, Urine, (And Accessories) For Indwelling Catheter
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964745 | AMSINO INTL., INC. |
833 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K971929 | AMSINO INTL., INC. |
833 TOWNE CENTER DR. | POMONA | CA | 91767 |
| K960949 | BRISTOL-MYERS SQUIBB |
100 HEADQUARTERS PARK DR. | SKILLMAN | NJ | 08558 |
| K964690 | CLEVELAND MEDICAL DEVICES, INC. |
11000 CEDAR AVE., SUITE 130 | CLEVELAND | OH | 44106 |
| K962652 | CUSTOMED, INC. |
CALLE IGUALDAD #7 | FAJARDO | PR | 00738 |
| K110518 | FUTURE PATH MEDICAL, LLC |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K973364 | MAERSK MEDICAL A/S |
HARLEV MARK 2 | HARLEV | 4652 | |
| K972887 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K971271 | UROLOGY RESEARCH INTL., INC. |
P.O. BOX 02544 | CLEVELAND | OH | 44102 |
| K971764 | WELCON, INC. |
99 HARTFORD AVE. | PROVIDENCE | RI | 02909 |
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