The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Sjm Attune Annuloplasty Ring.
| Device ID | K092876 |
| 510k Number | K092876 |
| Device Name: | SJM ATTUNE ANNULOPLASTY RING |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL 177 EAST COUNTY ROAD B St. Paul, MN 55117 |
| Contact | Thomas Tademacher |
| Correspondent | Thomas Tademacher 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 | 2009-09-18 |
| Decision Date | 2009-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734052177 | K092876 | 000 |
| 05414734029964 | K092876 | 000 |
| 05414734029971 | K092876 | 000 |
| 05414734029988 | K092876 | 000 |
| 05414734029995 | K092876 | 000 |
| 05414734030007 | K092876 | 000 |
| 05414734052146 | K092876 | 000 |
| 05414734052153 | K092876 | 000 |
| 05414734052160 | K092876 | 000 |
| 05414734029957 | K092876 | 000 |