The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cadd-tpn(tm) Ambulatory Infusion System.
| Device ID | K931113 |
| 510k Number | K931113 |
| Device Name: | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM |
| Classification | Pump, Infusion Or Syringe, Extra-luminal |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | W Numainville |
| Correspondent | W Numainville PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FIH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-04 |
| Decision Date | 1994-04-28 |