The following data is part of a premarket notification filed by Medical Infusion Technologies, Inc. with the FDA for Prepare Home Infusion Pump.
| Device ID | K983634 |
| 510k Number | K983634 |
| Device Name: | PREPARE HOME INFUSION PUMP |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | MEDICAL INFUSION TECHNOLOGIES, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Contact | Thomas L Parker |
| Correspondent | Thomas L Parker MEDICAL INFUSION TECHNOLOGIES, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1999-02-24 |
| Summary: | summary |