The following data is part of a premarket notification filed by Gerard Medical Enterprises, Inc. with the FDA for Trim-port(tm) Implant Access Syst Dual Titan Port.
| Device ID | K913114 |
| 510k Number | K913114 |
| Device Name: | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT |
| Classification | Syringe, Piston |
| Applicant | GERARD MEDICAL ENTERPRISES, INC. 90 WORCESTER RD. UNIT 2, BOX 6 Charlton, MA 01507 |
| Contact | Richard Cayer |
| Correspondent | Richard Cayer GERARD MEDICAL ENTERPRISES, INC. 90 WORCESTER RD. UNIT 2, BOX 6 Charlton, MA 01507 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1992-01-02 |