The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Prosthetic Rings #4400 Mitral & 4500.
| Device ID | K831949 |
| 510k Number | K831949 |
| Device Name: | PROSTHETIC RINGS #4400 MITRAL & 4500 |
| Classification | Ring, Annuloplasty |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-16 |
| Decision Date | 1983-07-29 |