The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cdd-pca(tm) Model 5800r Ambulatory Infusion Pump.
| Device ID | K911791 |
| 510k Number | K911791 |
| Device Name: | CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP |
| Classification | Pump, Infusion, Pca |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H.short |
| Correspondent | David H.short PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-06-11 |