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 | K133593 |
| 510k Number | K133593 |
| 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 | John Sheridan |
| Correspondent | John Sheridan 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-22 |
| Decision Date | 2014-03-24 |
| Summary: | summary |