The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cadd-tpa(tm) Model 5600 Ambulatory Infusion Pump.
| Device ID | K880204 |
| 510k Number | K880204 |
| Device Name: | CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Edward Numainville |
| Correspondent | Edward Numainville PHARMACIA DELTEC, 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 | 1988-01-19 |
| Decision Date | 1988-04-25 |