FDA 510(k) Applications for Medical Device:
Neurosurgical Paddie
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K031008 | AESCULAP |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K062406 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K112598 | AMERICAN SURGICAL COMPANY, LLC |
82 SANDERSON AVENUE | LYNN | MA | 01902 |
| K121822 | AMERICAN SURGICAL COMPANY, LLC |
82 SANDERSON AVENUE | LYNN | MA | 01902 |
| K962807 | AMERICAN SURGICAL SPONGES |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K073576 | HAROD ENTERPRISES, INC. |
4052 INDIAN CREEK ROAD | MARTINEZ | GA | 30907 |
| K193346 | Integra LifeSciences Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K140369 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60006 |
| K014268 | PERLEI MEDICAL, INC. |
962 ALLEGRO LN. | APOLLO BEACH | FL | 33572 |
| K020736 | TRAATEK, INC. |
917 DURISTON RD. | REDWOOD CITY | CA | 94062 |
| K973083 | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
183 PROVIDENCE, NEW LONDON | NORTH STONINGTON | CT | 06359 |
| K970328 | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 | NORTH STONINGTON | CT | 06359 |
| K993019 | V. MUELLER NEURO/SPINE |
360 INDUSTRIAL RD., UNIT H | SAN CARLOS | CA | 94070 |
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