The following data is part of a premarket notification filed by Gerard Medical Enterprises, Inc. with the FDA for Modified Version Implantable Vascular Access Syste.
| Device ID | K912111 |
| 510k Number | K912111 |
| Device Name: | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE |
| Classification | Syringe, Piston |
| Applicant | GERARD MEDICAL ENTERPRISES, INC. P.O. BOX 348 Brimfield, MA 01010 |
| Contact | Cayer, Jr. |
| Correspondent | Cayer, Jr. GERARD MEDICAL ENTERPRISES, INC. P.O. BOX 348 Brimfield, MA 01010 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-10-08 |