FDA 510(k) Applications for Medical Device:
Light, Surgical, Accessories
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K020304 | ASPEN SURGICAL PRODUCTS, INC. |
7425 CLYDE PARK, SUITE G | GRAND RAPIDS | MI | 49315-0404 |
| K133413 | BLACK DIAMOND VIDEO |
503 CANAL BLVD. | RICHMOND | CA | 94804 |
| K993089 | DEROYAL CARDIOVASCULAR, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K102791 | IMAGE STREAM MEDICAL, INC. |
ONE MONARCH DR. | LITTLETON | MA | 01460 |
| K081698 | IMAGE STREAM MEDICAL, INC. |
11 MYSTIC AVE. | WINCHESTER | MA | 01890-2920 |
| K023704 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE 5TH FLOOR | CULVER CITY | CA | 90230-7600 |
| K020640 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE 5TH FLOOR | CULVER CITY | CA | 90230-7600 |
| K051505 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K150532 | Key Surgical, Inc. |
8101 Wallace Road | Eden Prairie | MN | 55344 |
| K142386 | Litex Manufacturing, Inc. |
1501 Sunshine Drive | Glendale | CA | 91208 |
| K954940 | MDT BIOLOGIC CO. |
1777 EAST HENRIETTA RD. | ROCHESTER | NY | 14692 |
| K133554 | MICROTEK MEDICAL, INC. AN ECOLAB COMPANY |
370 WABASHA STREET N | ST. PAUL | MN | 55102 |
| K112133 | OASYS HEALTHCARE |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K053321 | XODUS MEDICAL, INC. |
702 PROMINENCE DR. | NEW KENSINGTON | PA | 15068 |
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