The following data is part of a premarket notification filed by Deltec Systems, Inc. with the FDA for Cadd-1 5100 Ambulatory Infusion Pump.
| Device ID | K843772 |
| 510k Number | K843772 |
| Device Name: | CADD-1 5100 AMBULATORY INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | DELTEC SYSTEMS, INC. 3800 NORTH DUNLAP AVENUE St. Paul , MN 55112 - |
| Contact | Thomas A Dougherty |
| Correspondent | Thomas A Dougherty DELTEC SYSTEMS, INC. 3800 NORTH DUNLAP AVENUE 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 | 1984-09-25 |
| Decision Date | 1984-12-06 |