The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Pharmacia Deltec Winged Infusion Set.
| Device ID | K923019 |
| 510k Number | K923019 |
| Device Name: | PHARMACIA DELTEC WINGED INFUSION SET |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-23 |
| Decision Date | 1993-04-21 |