FDA 510(k) Applications for Medical Device:
Detector, Bubble, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K071231 | LUNA INNOVATIONS, INC. |
3157 STATE STREET | BLACKSBURG | VA | 24060 |
| K961364 | ROCKY MOUNTAIN RESEARCH, INC. |
825 NORTH 300 WEST, SUITE 500 | SALT LAKE CITY | UT | 84103 |
| K961598 | ROCKY MOUNTAIN RESEARCH, INC. |
2715 EAST 3300 SOUTH | SALT LAKE CITY | UT | 84109 |
| K103469 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K090698 | TERUMO CARDIOVASCULAR SYSTEMS |
125 Blue Ball Road | Elkton | MD | 21921 |
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