The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Carbomedics Supra-annular Valve Sizer.
| Device ID | K952184 |
| 510k Number | K952184 |
| Device Name: | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER |
| Classification | Sizer, Heart-valve, Prosthesis |
| 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 | DTI |
| CFR Regulation Number | 870.3945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1995-11-29 |