The following data is part of a premarket notification filed by Advanced Infusion, Inc. with the FDA for Alpha Infusion Pump And Catheters.
| Device ID | K021964 |
| 510k Number | K021964 |
| Device Name: | ALPHA INFUSION PUMP AND CATHETERS |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | ADVANCED INFUSION, INC. 6200 SOUTH MCCLINTOCK #6 Tempe, AZ 85283 |
| Contact | James Christensen |
| Correspondent | James Christensen ADVANCED INFUSION, INC. 6200 SOUTH MCCLINTOCK #6 Tempe, AZ 85283 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-14 |
| Decision Date | 2002-08-12 |
| Summary: | summary |