The following data is part of a premarket notification filed by Deltec Systems, Inc. with the FDA for Cadd-1, Model 5100 Hf.
| Device ID | K862927 |
| 510k Number | K862927 |
| Device Name: | CADD-1, MODEL 5100 HF |
| Classification | Pump, Infusion |
| Applicant | DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
| Contact | James E Leslie |
| Correspondent | James E Leslie DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-01 |
| Decision Date | 1986-08-27 |