The following data is part of a premarket notification filed by Gerard Medical Enterprises, Inc. with the FDA for Gerard Medical, Inc. Trim-port.
| Device ID | K903364 |
| 510k Number | K903364 |
| Device Name: | GERARD MEDICAL, INC. TRIM-PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-26 |
| Decision Date | 1990-10-31 |