The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Carbomedics Exended Mitral Rotator.
| Device ID | K951368 |
| 510k Number | K951368 |
| Device Name: | CARBOMEDICS EXENDED MITRAL ROTATOR |
| Classification | Rotator, Prosthetic Heart Valve |
| Applicant | CARBOMEDICS, INC. 1300-A EAST ANDERSON LN. Austin, TX 78752 -1708 |
| Contact | Joy F Shugart |
| Correspondent | Joy F Shugart CARBOMEDICS, INC. 1300-A EAST ANDERSON LN. Austin, TX 78752 -1708 |
| Product Code | MOP |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08022057014030 | K951368 | 000 |