FDA 510(k) Applications for Medical Device:
Drills, Burrs, Trephines & Accessories (Manual)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961113 | CLINICAL NEURO SYSTEMS LLC. |
309 COMMERCE DR. | EXTON | PA | 19341 |
| K022712 | MEDICAL DESIGN LLC. |
213 SUNSET DR. | BRANDON | SD | 57005 |
| K022370 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K122456 | MRI INTERVENTIONS, INC. |
5 MUSICK | IRVINE | CA | 92618 |
| K160129 | MRI INTERVENTIONS, INC. |
5 MUSICK | IRVINE | CA | 92618 |
| K151536 | MRI INTERVENTIONS, INC. |
5 MUSICK | IRVINE | CA | 92618 |
| K162884 | SPINEGUARD,S.A. |
10 cours Louis Lumiere | Vincennes | 94300 | |
| K153587 | SYNTHES (USA) PRODUCTS LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
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