The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Annuloflex Annuoplasty System, Model Af 800.
| Device ID | K023185 |
| 510k Number | K023185 |
| Device Name: | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 |
| Classification | Ring, Annuloplasty |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Teffany Hankinson |
| Correspondent | Teffany Hankinson SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-24 |
| Decision Date | 2002-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08022057013651 | K023185 | 000 |
| 08022057013644 | K023185 | 000 |
| 08022057013637 | K023185 | 000 |
| 08022057013620 | K023185 | 000 |
| 08022057013613 | K023185 | 000 |
| 08022057013606 | K023185 | 000 |