The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Infusion Pump Enclosure.
Device ID | K872821 |
510k Number | K872821 |
Device Name: | INFUSION PUMP ENCLOSURE |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-17 |
Decision Date | 1987-07-27 |