The following data is part of a premarket notification filed by Deltec, Inc. with the FDA for Deltec Insulin Infusion Pump And Accessories.
| Device ID | K020655 |
| 510k Number | K020655 |
| Device Name: | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES |
| Classification | Pump, Infusion, Insulin |
| Applicant | DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-08-13 |
| Summary: | summary |