Gerard Medical Enterprises, Inc. · Class II · Cleared Oct 8, 1991
| K-number | K912111 |
| Device name | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE |
| Applicant | Gerard Medical Enterprises, Inc. |
| Product code | FMF |
| Device class | Class II |
| Decision date | Oct 8, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 880.5860 |
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