The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Semi-rigid Mitral Annuloplasty Ring, Model 800sr.
| Device ID | K072655 |
| 510k Number | K072655 |
| Device Name: | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR |
| Classification | Ring, Annuloplasty |
| Applicant | Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223 |
| Contact | John T Wright, Ph.d. |
| Correspondent | John T Wright, Ph.d. 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 | 2007-09-20 |
| Decision Date | 2007-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994867148 | K072655 | 000 |
| 00643169182288 | K072655 | 000 |
| 00643169182271 | K072655 | 000 |
| 00643169182264 | K072655 | 000 |
| 00643169182257 | K072655 | 000 |
| 00643169182240 | K072655 | 000 |
| 00643169182233 | K072655 | 000 |
| 00643169182226 | K072655 | 000 |
| 00643169182110 | K072655 | 000 |
| 00643169300972 | K072655 | 000 |
| 00643169300989 | K072655 | 000 |
| 00613994867094 | K072655 | 000 |
| 00643169301054 | K072655 | 000 |
| 00643169301047 | K072655 | 000 |
| 00643169301030 | K072655 | 000 |
| 00643169301023 | K072655 | 000 |
| 00643169301016 | K072655 | 000 |
| 00643169301009 | K072655 | 000 |
| 00643169300996 | K072655 | 000 |
| 00643169182103 | K072655 | 000 |