The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Geoform Annuloplasty Ring, Mitral Model 4200.
| Device ID | K032250 |
| 510k Number | K032250 |
| Device Name: | GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 |
| Classification | Ring, Annuloplasty |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Susan Reynolds |
| Correspondent | Susan Reynolds EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-22 |
| Decision Date | 2003-08-26 |
| Summary: | summary |