The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Annuloplasty Ring, Model 700ff.
| Device ID | K052565 |
| 510k Number | K052565 |
| Device Name: | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF |
| Classification | Ring, Annuloplasty |
| Applicant | Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223 |
| Contact | John T. M. Wright |
| Correspondent | John T. M. 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 | 2005-09-19 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994867001 | K052565 | 000 |
| 00643169182318 | K052565 | 000 |
| 00643169182325 | K052565 | 000 |
| 00643169182424 | K052565 | 000 |
| 00643169182509 | K052565 | 000 |
| 00643169182516 | K052565 | 000 |
| 00643169182523 | K052565 | 000 |
| 00643169182530 | K052565 | 000 |
| 00643169182547 | K052565 | 000 |
| 00613994866929 | K052565 | 000 |
| 00643169182301 | K052565 | 000 |