The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Carbomedics Handle.
| Device ID | K962154 |
| 510k Number | K962154 |
| Device Name: | CARBOMEDICS HANDLE |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Joy Fisher-shugart |
| Correspondent | Joy Fisher-shugart CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-04 |
| Decision Date | 1996-08-27 |
| Summary: | summary |