The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Flexform Annuloplasty Ring And Flexform Annuloplasty Band.
| Device ID | K161815 |
| 510k Number | K161815 |
| Device Name: | FlexForm Annuloplasty Ring And FlexForm Annuloplasty Band |
| Classification | Ring, Annuloplasty |
| Applicant | Genesee BioMedical, Inc. 700 W. Mississippi Ave Unit D-5 Denver, CO 80223 -4509 |
| Contact | Woodrow G. Mathison |
| Correspondent | Woodrow G. Mathison Genesee BioMedical, Inc. 700 W. Mississippi Ave Unit D-5 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 | 2016-07-01 |
| Decision Date | 2016-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B040FRN40 | K161815 | 000 |
| B040FBN38 | K161815 | 000 |
| B040FBN36 | K161815 | 000 |
| B040FBN34 | K161815 | 000 |
| B040FBN320 | K161815 | 000 |
| B040FBN30 | K161815 | 000 |
| B040FBN28 | K161815 | 000 |
| B040FBN26 | K161815 | 000 |
| B040FBN24 | K161815 | 000 |
| B040FBH40 | K161815 | 000 |
| B040FBH38 | K161815 | 000 |
| B040FBH36 | K161815 | 000 |
| B040FBH34 | K161815 | 000 |
| B040FBH32 | K161815 | 000 |
| B040FBH30 | K161815 | 000 |
| B040FBH28 | K161815 | 000 |
| B040FBH26 | K161815 | 000 |
| B040FBN40 | K161815 | 000 |
| B040FRH24 | K161815 | 000 |
| B040FRN38 | K161815 | 000 |
| B040FRN36 | K161815 | 000 |
| B0040FRN34 | K161815 | 000 |
| B040FRN32 | K161815 | 000 |
| B040FRN30 | K161815 | 000 |
| B040FRN28 | K161815 | 000 |
| B040FRN26 | K161815 | 000 |
| B040FRN240 | K161815 | 000 |
| B040FRH40 | K161815 | 000 |
| B040FRH38 | K161815 | 000 |
| B040FRH36 | K161815 | 000 |
| B040FRH34 | K161815 | 000 |
| B040FRH32 | K161815 | 000 |
| B040FRH30 | K161815 | 000 |
| B040FRH28 | K161815 | 000 |
| B040FRH26 | K161815 | 000 |
| B040FBH24 | K161815 | 000 |