The following data is part of a premarket notification filed by Electrochemical Drug Delivery, Inc. with the FDA for Infu.disk.
| Device ID | K904619 |
| 510k Number | K904619 |
| Device Name: | INFU.DISK |
| Classification | Pump, Infusion |
| Applicant | ELECTROCHEMICAL DRUG DELIVERY, INC. 10633 ROSELLE SUITE E San Diego, CA 92121 |
| Contact | Coni Rosati |
| Correspondent | Coni Rosati ELECTROCHEMICAL DRUG DELIVERY, INC. 10633 ROSELLE SUITE E San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1991-11-05 |