The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Adjustable Flexible Annuloplasty Ring.
| Device ID | K071214 |
| 510k Number | K071214 |
| Device Name: | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING |
| Classification | Ring, Annuloplasty |
| Applicant | Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223 |
| Contact | John T Wright |
| Correspondent | John T Wright Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-01 |
| Decision Date | 2007-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169182486 | K071214 | 000 |
| 00643169182479 | K071214 | 000 |
| 00643169182462 | K071214 | 000 |
| 00643169182455 | K071214 | 000 |
| 00643169182448 | K071214 | 000 |
| 00643169182431 | K071214 | 000 |
| 00643169182295 | K071214 | 000 |
| 00643169182219 | K071214 | 000 |