The following data is part of a premarket notification filed by Cane Srl with the FDA for Microjet Quark, Model U100 Or U40.
| Device ID | K013807 |
| 510k Number | K013807 |
| Device Name: | MICROJET QUARK, MODEL U100 OR U40 |
| Classification | Pump, Infusion, Insulin |
| Applicant | CANE SRL P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm CANE SRL P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-15 |
| Decision Date | 2001-12-12 |
| Summary: | summary |