The following data is part of a premarket notification filed by Asante Solutions, Inc with the FDA for Snap Insulin Pump System.
| Device ID | K142619 |
| 510k Number | K142619 |
| Device Name: | Snap Insulin Pump System |
| Classification | Pump, Infusion, Insulin |
| Applicant | ASANTE SOLUTIONS, INC 352 EAST JAVA DRIVE Sunnyvale, CA 94089 |
| Contact | Edward Sinclair |
| Correspondent | Edward Sinclair ASANTE SOLUTIONS, INC 352 EAST JAVA DRIVE Sunnyvale, CA 94089 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2014-12-18 |
| Summary: | summary |