The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Sjm Seguin Annuloplasty Ring Model Sar-m.
| Device ID | K961246 |
| 510k Number | K961246 |
| Device Name: | SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Contact | Jonas Runquist |
| Correspondent | Jonas Runquist ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| 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 | 1996-04-01 |
| Decision Date | 1997-02-14 |
| Summary: | summary |