FDA 510(k) Applications for Medical Device Product Code "MOP"
(Rotator, Prosthetic Heart Valve)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K960923 | CARBOMEDICS, INC. | CARBOMEDICS MITRAL ROTATOR | 04/29/1996 |
| K980016 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | 08/07/1998 |
| K974648 | SULZER CARBOMEDICS, INC. | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | 08/04/1998 |
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