The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for T:slim (tm) Insulin Delivery System.
| Device ID | K111210 |
| 510k Number | K111210 |
| Device Name: | T:SLIM (TM) INSULIN DELIVERY SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | TANDEM DIABETES CARE, INC. 11045 ROSELLE STREET SUITE 200 San Diego, CA 92121 |
| Contact | Don Canal |
| Correspondent | Don Canal TANDEM DIABETES CARE, INC. 11045 ROSELLE STREET SUITE 200 San Diego, CA 92121 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-11-09 |
| Summary: | summary |