The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Attune Adjustable Flexible Annuloplasty Ring Model Afr.
| Device ID | K083835 |
| 510k Number | K083835 |
| Device Name: | ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul, MN 55117 |
| Contact | William Mckelvey |
| Correspondent | William Mckelvey ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul, MN 55117 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-23 |
| Decision Date | 2009-01-23 |
| Summary: | summary |