The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Carbomedics Mitral Rotator.
| Device ID | K960923 |
| 510k Number | K960923 |
| Device Name: | CARBOMEDICS MITRAL ROTATOR |
| Classification | Rotator, Prosthetic Heart Valve |
| Applicant | CARBOMEDICS, INC. 1300-C EAST ANDERSON LN. Austin, TX 78752 |
| Contact | David M Makanani |
| Correspondent | David M Makanani CARBOMEDICS, INC. 1300-C EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | MOP |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-04-29 |
| Summary: | summary |