The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Aviator Insulin Pump.
| Device ID | K071788 |
| 510k Number | K071788 |
| Device Name: | AVIATOR INSULIN PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2008-01-11 |
| Summary: | summary |