The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Remote Reservoir Adapter Cassette W/bag Spike.
| Device ID | K895046 |
| 510k Number | K895046 |
| Device Name: | REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-09 |
| Decision Date | 1989-10-25 |