The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Annuloflex Annuloplasty System, Model Af800.
| Device ID | K992056 |
| 510k Number | K992056 |
| Device Name: | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 |
| Classification | Ring, Annuloplasty |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Robert M Wolfarth |
| Correspondent | Robert M Wolfarth 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 | 1999-06-18 |
| Decision Date | 1999-10-12 |
| Summary: | summary |