| K-number | K042809 |
| Device name | CUFFPATCH |
| Applicant | Organogenesis, Inc. |
| Product code | FTM |
| Device class | Class II |
| Decision date | Nov 2, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
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