The following data is part of a premarket notification filed by Gerard Medical Enterprises, Inc. with the FDA for Dual Plastic Vascular Access System.
| Device ID | K922147 |
| 510k Number | K922147 |
| Device Name: | DUAL PLASTIC VASCULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | GERARD MEDICAL ENTERPRISES, INC. 90 WORCESTER RD. UNIT 2, BOX 6 Charlton, MA 01507 |
| Contact | Cayer, Jr. |
| Correspondent | Cayer, Jr. GERARD MEDICAL ENTERPRISES, INC. 90 WORCESTER RD. UNIT 2, BOX 6 Charlton, MA 01507 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-07 |
| Decision Date | 1992-12-04 |