The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for T:flex Insulin Delivery System.
| Device ID | K143189 |
| 510k Number | K143189 |
| Device Name: | T:flex Insulin Delivery System |
| Classification | Pump, Infusion, Insulin |
| Applicant | Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 |
| Contact | John Sheridan |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-05 |
| Decision Date | 2015-01-09 |
| Summary: | summary |