The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for T:slim Insulin Delivery System.
| Device ID | K141758 |
| 510k Number | K141758 |
| Device Name: | T:SLIM INSULIN DELIVERY SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | TANDEM DIABETES CARE, INC. 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice Hogan |
| Correspondent | Janice Hogan TANDEM DIABETES CARE, INC. 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 | 2014-06-30 |
| Decision Date | 2014-10-31 |
| Summary: | summary |