Genesee Biomedical, Inc. · Class II · Cleared Feb 25, 2009
| K-number | K083683 |
| Device name | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC |
| Applicant | Genesee Biomedical, Inc. |
| Product code | KRH |
| Device class | Class II |
| Decision date | Feb 25, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 870.3800 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov