The following data is part of a premarket notification filed by Applied Diabetes Research, Inc. with the FDA for Thinset 1.8 Ml Reservoir, Model 326a; Thinset 3.0 Ml Reservoir, Model 332a.
| Device ID | K041152 |
| 510k Number | K041152 |
| Device Name: | THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A |
| Classification | Pump, Infusion |
| Applicant | APPLIED DIABETES RESEARCH, INC. PO BOX 3900 Dana Point, CA 92629 |
| Contact | Jim Barley |
| Correspondent | Jim Barley APPLIED DIABETES RESEARCH, INC. PO BOX 3900 Dana Point, CA 92629 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-05-24 |
| Summary: | summary |