The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Annuloflo System.
| Device ID | K970375 |
| 510k Number | K970375 |
| Device Name: | ANNULOFLO SYSTEM |
| Classification | Ring, Annuloplasty |
| Applicant | CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Michael C Morton |
| Correspondent | Michael C Morton CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-07-25 |
| Summary: | summary |