The following data is part of a premarket notification filed by Genesee Biomedical, Inc with the FDA for Neoform Annuloplasty Ring.
| Device ID | K190506 |
| 510k Number | K190506 |
| Device Name: | NeoForm Annuloplasty Ring |
| Classification | Ring, Annuloplasty |
| Applicant | Genesee BioMedical, Inc 700 W Mississippi Ave, Unit D5 Denver, CO 80223 -4509 |
| Contact | Woodrow Mathison |
| Correspondent | Woodrow Mathison Genesee BioMedical, Inc 700 W Mississippi Ave, Unit D5 Denver, CO 80223 -4509 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B040420032 | K190506 | 000 |
| B040420030 | K190506 | 000 |
| B040420028 | K190506 | 000 |
| B0404200260 | K190506 | 000 |