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 800sc.
| Device ID | K083683 |
| 510k Number | K083683 |
| Device Name: | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC |
| 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 | 2008-12-12 |
| Decision Date | 2009-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169300934 | K083683 | 000 |
| 00643169182134 | K083683 | 000 |
| 00643169182141 | K083683 | 000 |
| 00643169182158 | K083683 | 000 |
| 00643169182165 | K083683 | 000 |
| 00643169182172 | K083683 | 000 |
| 00643169182189 | K083683 | 000 |
| 00643169182196 | K083683 | 000 |
| 00643169182202 | K083683 | 000 |
| 00643169300880 | K083683 | 000 |
| 00643169300897 | K083683 | 000 |
| 00643169300903 | K083683 | 000 |
| 00643169300910 | K083683 | 000 |
| 00643169300927 | K083683 | 000 |
| 00643169182127 | K083683 | 000 |